Outcomes of the consultation on the draft list of permitted indications

8 May 2018

The permitted indication reform has now been launched. Please see Permitted Indications now available for use in Listed Medicines for more information.

Background

On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act).

Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list can also be accessed via the TGA Business Services website

For more information see Permitted Indications now available for use in Listed Medicines and Permitted indications for listed medicines guidance.

Development and consultation on the list of permitted indications

Extensive consultation was undertaken on the draft list of permitted indications.

  • In February 2017 a public consultation paper, Consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways was released detailing proposed criteria and implementation options for the permitted indications reform. Submissions received and TGA responses are published on the TGA website.
  • An initial draft list of permitted indications was developed based on industry submissions to previous TGA consultations and refined following several targeted stakeholder consultation forums in 2017.
  • In July 2017, draft lists of permitted indications and indication qualifiers were published on the TGA website for a 3 month public comment period, which closed 31 October 2017. At the end of the 3 month comment period, 110 submissions were received, consisting of 11 consumer group submissions and 99 industry submissions.
  • From these submissions a number of issues were raised by stakeholders and a large number of additional indications were proposed for inclusion in the list of permitted indications. A summary of industry comments and the TGA's consideration of these issues are provided below.
  • In finalising the list of permitted indications, advice was sought from internal and external experts, including the Advisory Committee on Complementary Medicines (ACCM).

Outcome summary

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Stakeholder comment

Industry stakeholders submitted that indications covered by the existing advertising exemptions for substance based restricted representations for vitamin D and calcium (referring to osteoporosis) and folic acid (referring to neural tube defects) have a safe history of use and an established evidence base and should be included in the list of permitted indications.

TGA response

The TGA agreed that indications linked to vitamin D, calcium and folic acid have a safe history of use and established evidence base. Indications covered by the existing substance based restricted representations for these ingredients are included in the list of permitted indications. In order to be used in listed medicines, sponsors must continue to comply with the requirements for the current advertising exemptions.

Stakeholder comment

Industry stakeholders submitted that indications making biomarker claims (i.e. referring to maintenance of blood glucose or cholesterol levels) are low risk and do not refer to or imply a health benefit for serious conditions. It was requested that all current 'standard indications' referring to biomarkers be included in the list of permitted indications.

Industry suggested that a mandatory label warning (for example, 'not for treatment of high cholesterol') would mitigate any potential risks posed by products using biomarker indications.

TGA response

The TGA sought advice from ACCM on the appropriate risk stratification for biomarker indications. ACCM advised that indications referring to maintenance, management or control of biomarker levels, ratios and ranges should not be included in the permitted indications list. The TGA accepted this advice.

The new assessed listed medicines pathway and the registered pathway are options to enable sponsors to make higher-level indications (such as biomarker claims) than are allowable under the standard listing pathway.

Stakeholder comment

Industry stakeholders submitted that foetuses should be available as a target population qualifier to enable indications for foetal growth and development.

Industry stakeholders also submitted that the proposed label advisory statement, 'Not to be taken in first trimester of pregnancy unless under medical advice', will cause undue alarm for pregnant women.

TGA response

The TGA sought advice from ACCM on the inclusion of indications for pregnancy and foetal development. ACCM advised that foetuses are a potentially vulnerable population group. Allowing a 'foetus' population qualifier to be available for selection for any permitted indication, without any mitigation measures, is not commensurate with the low risk nature of listed medicines. The TGA has accepted ACCM's advice and a 'foetus' target population qualifier is not available. However, a number of specific indications for this population group are included in the list, such as, 'Maintains/ support healthy foetal development'.

Industry concerns about the wording of the advisory statement for indications referring to pregnancy were acknowledged and the statement, 'Not to be taken in first trimester of pregnancy unless under medical advice' has been amended to: 'Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester'.

Stakeholder comment

Industry stakeholders submitted that indications referring to the following 'medically diagnosed' conditions should be included in the permitted indications list:

  • Benign Prostatic Hypertrophy
  • Chronic Fatigue Syndrome
  • Tinnitus

TGA response

For a limited number of conditions, it may be appropriate for a consumer to self-manage and assess the symptoms of their condition after an initial diagnosis has been made by a medical practitioner (where other diseases and conditions have been ruled out). For example: 'Relief of symptoms of medically diagnosed Irritable Bowel Syndrome'.

However, serious forms of diseases, conditions, ailments or defects that require ongoing supervision by a medical practitioner are restricted representations and cannot be qualified by 'medically diagnosed'. These indications are not suitable for listed medicines that are not assessed pre-market. Indications relating to these conditions are not included in the list of permitted indications. Sponsors wishing to make these indications will need to use a pre-assessment pathway for their medicine (registered or assessed listed).

Stakeholder comment

Industry stakeholders submitted that in many cases, the requirement that certain indications be qualified with 'mild' is unnecessary and potentially confusing for consumers. They felt it would be more informative to consumers if the 'mild' qualifier was removed from a number of indications.

TGA response

The qualifier 'mild' has been used for certain indications to ensure that listed medicines cannot refer to serious forms of disease or condition. For example, the qualifier 'mild' has been included in 'mild osteoarthritis'.

Where an indication is qualified with 'mild' it is a requirement that this qualifying term is used on the medicine label.

Stakeholder comment

Industry stakeholders submitted that in some circumstances it is appropriate for certain conditions to be qualified with the term 'moderate'. They submitted that referencing more advanced stages of these non-threatening but progressive illnesses are appropriate for low risk medicines.

TGA response

The TGA maintains that indications referring to 'moderate' conditions are not appropriate for low risk listed medicines.

Sponsors wishing to make these types of indications will need to use a pre-assessment pathway for their medicine (registered or listed assessed).

Stakeholder comment

When the Australian and New Zealand Sunscreen Standard AS/NZS 2604:2012 came into effect in 2012, sunscreen products listed prior to 2012 could comply with the 1998 Standard (AS/NZS 2604:1998) as long as they did not make any major changes to their product.

Industry stakeholders complained that requiring existing sponsors of sunscreens products to re-list using permitted indications will now force these products to comply with the latest version of the Australian and New Zealand Sunscreen Standard, AS/NZS 2604:2012, even though these products were given an exemption in 2012.

TGA response

When the 2012 sunscreen standard came into effect, sunscreen products listed prior November 2012 could continue to comply with the 1998 sunscreen standard as a phase out arrangement to avoid major disruption of the supply of sunscreens in Australia. TGA analysis of sunscreen therapeutic products currently in the Register indicates that over 70% of sunscreens should now be compliant with the 2012 sunscreen standard.

Requiring the remaining sunscreen products to comply with the 2012 sunscreen standard from the time they transition to the permitted indications is not unreasonable, given that the new standard has now been in place for 5 years and, the public health importance of sunscreens in Australia. There is a 3 year transition period for listed medicines sponsors to re-list their products using permitted indications and to comply with the 2012 sunscreen standard.

Stakeholder comment

There were mixed stakeholder views on the inclusion of cellular level indications (for example: 'For DNA synthesis') in the list of permitted indications.

Some stakeholders argued that these claims are not therapeutic indications, not meaningful to the consumer and should be removed from the list. However, others argued that cellular level indications are required in the list as they help consumers understand how the medicine works.

TGA response

The TGA sought advice from ACCM on this issue. ACCM advised TGA that 'cellular level indications' that describe a structure, function or mechanism of action are not therapeutic indications and should not be included in the permitted indications list. The Committee noted that there is no therapeutic context for these types of statements and they may not be understandable or provide useful information to consumers.

The TGA accepted ACCM's advice and in general, cellular level indications are not included in the list of permitted indications.

Stakeholder comment

Consumers raised concerns that the specific terminology used in Ayurvedic and Chinese traditional medicine indications will not be understood by the general consumer.

TGA response

TCM and Ayurvedic medicine terminology have been included in the list in recognition that traditional terminology is required for persons familiar with these paradigms to use the medicines appropriately.The TGA's approach of including TCM and Ayurvedic medicine specific indications and supporting terminology is consistent with international developments. As part of the its Traditional Medicine Strategy, the World Health Organisation recommends that all member states appropriately include traditional medicine terms in their regulatory, legislative and policy initiatives around traditional and complementary medicine products and practices.

On the issue of traditional terminology not being understood by consumers unfamiliar with the traditional paradigm, ACCM advised the TGA that there should be a label advisory statement to encourage consumers to consult their health practitioner. The TGA accepted ACCM's advice and medicines using Ayurvedic and TCM indications are required to include the following label advisory statement: 'Please seek the advice of a traditional Chinese (or Ayurvedic) medicine practitioner if you are unsure if this medicine is right for you'.

The inclusion of a mandatory label advisory statement is aimed at addressing consumer concerns that TCM and Ayurvedic indications using paradigm specific terminology have the potential to confuse consumers, such as 'Support protective Qi'. These indications use terminology that is not in English and so cannot be understood by average consumers who are not familiar with the paradigm. The advisory is therefore intended to encourage consumers to seek advice from e.g. a TCM practitioner prior to initial/continuous usage.

Other traditional indications that do not use specific terminology (i.e. they are in English) and can be more easily understood by consumers do not require the label advisory statement.

Stakeholder comment

Consumers submitted that a mandatory label warning statement (or 'disclaimer') should be enforced for medicines using traditional indications, such as: 'This product's traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works'.

TGA response

In responding to the Review of Medicines and Medical Devices Regulation, the Government 'supported the intent' of the recommendation for a disclaimer for listed medicines, but will not require sponsors to place a disclaimer on product labels.

The legislative instrument for permitted indications introduces an additional regulatory requirement for medicines including traditional indications on their medicine label. These medicines must now state that the indication is based on traditional evidence and, specify the traditional paradigm e.g. 'Traditionally used in Chinese herbal medicine'.

In addition, medicines using indications with TCM or Ayurvedic specific terminology must include a label statement such as 'Please seek the advice of a traditional Chinese (or Ayurvedic) medicine practitioner if you are unsure if this medicine is right for you'.

Stakeholder comment

Some stakeholders submitted that there is no evidence to support many of the indications included in the draft list.

TGA response

Complementary medicines encompass a wide range of products, with varying sources of evidence on their efficacy, and a history of use related to cultural and traditional values as well as on the basis of consumer health preferences.

It is not correct to say that there is no evidence to support many proposed permitted indications. Consistent with current arrangements, the permitted indications list includes indications that may be supported by evidence sourced from scientific literature or evidence of traditional use (for example, based on long-term use and experience in a specific traditional paradigm outside modern conventional medicine, such as traditional Chinese medicine).

Consistent with current arrangements, evidence to support the use of permitted indications must be held by product sponsors and this may be requested and assessed by the TGA as part of the TGA's post market compliance program.

Stakeholder comment

Some stakeholders submitted that the list should only include a small number of very modest indications. They also submitted that all indications should be qualified with 'May help' to prevent consumers from being misled.

TGA response

Indications that meet the eligibility criteria for permitted indications have been included in the final proposed list of permitted indications. These criteria are included in our Permitted indications for listed medicines guidance.

The criteria ensure that listed medicines can only make low level indications that are suitable for low risk listed medicines that do not undergo pre market assessment by the TGA. The criteria also ensure that the list of permitted indications is comprehensive and flexible enough to meet the needs of sponsors and consumers.

In general, the word 'may' has not been used in permitted indications as it can imply that the sponsor does not have evidence of sufficient quality to show that their medicine is effective. This is not consistent with the legislative requirement for sponsors to hold evidence for the indications they make for their medicine.

Stakeholder comment

Approximately 3000 additional indications were proposed for inclusion in the list of permitted indications during the open comment period.

TGA response

The TGA reviewed the proposed indications against the criteria for permitted indications. A number of the proposed indications were included in the final list. However, many indications were not included in the list, as they were considered to:

  • be covered by indications already in the list of permitted indications that are similar in intent
  • not meet the criteria for permitted indications, because they:
    • are not scientifically plausible
    • are not compliant with the advertising code, for example: they implied harm would occur if the medicine is not taken
    • imply restricted representations
    • refer to treatment/cure/prevention
  • describe a structure, function or mechanism of action (for example, cellular level indications)
  • be cosmetic claims
  • be not compliant with the sunscreen guidelines

What do I do now?

Sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. The application form is available after logging in to your sponsor portal via the TGA Business Services website. An application fee applies.

For more information, please see Permitted indications in listed medicines guidance.

Files for download

How to access a pdf document

Permitted indications for listed medicines guidance

Permitted indications fact sheets

Draft list of permitted indications - CLOSED

Draft lists of evidence qualifiers - CLOSED

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