the complementary medicines reform and its impact to the complementary medicine industry and the consumer lina karlina 2014

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Lina Karlina (2067226) Page 1_of25

CHE8000 Major Research Project A

The Complementary Medicines Reforms and Its Impact to the

Complementary Medicine Industry and the Consumer

Completed by: Lina Karlina (ID: 2067226)

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Lina Karlina (2067226) Page 2_of25 TABLE OF CONTENTS

Abstract ... 6

1 Introduction ... 6

1.1 Background ... 6

1.2 Purpose ... 9

2 Literature Review ... 9

2.1 Therapeutic Goods Administration (TGA) ... 9

2.2 Complementary Medicines ... 10

3 Methodology ... 11

4 Discussion ... 12

4.1 Complementary Medicines Reforms ... 12

4.1.1 Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)... 14

4.1.2 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines ... 14

4.1.3 Update to the listed medicines electronic application portal ... 15

4.1.4 Enhancing post-market monitoring ... 15

4.1.5 Publishing outcomes of listing compliance reviews ... 15

4.1.6 Permitted (coded) indications project ... 16

4.1.7 Investigation process for advertising breaches ... 16

4.2 Impact of Complementary Medicine Reforms to the Industry and the Consumer ... 18

5 Conclusion and Recommendation ... 23

5.1 Conclusion ... 23

5.2 Recommendation ... 24

List of Tables ... 3

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Lina Karlina (2067226) Page 3_of25 References ... 24 Bibliography ... 25

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Lina Karlina (2067226) Page 4_of25 List of Tables

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Lina Karlina (2067226) Page 5_of25 List of Pictures

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Lina Karlina (2067226) Page 6_of25 The Complementary Medicines Reforms and Its Impact to the Complementary Medicine

Industry and the Consumer

Abstract

It is identified that complementary medicine industry in Australia is continuously growing. This is due to the increasing use of complementary medicines which may be cause by the assumption that complementary medicines are risk-free, safer and only contains natural ingredients as well as the search for alternative or a substitute of conventional medicines. According to the result of post-market compliance review conducted by the Therapeutic Goods Administration (TGA) in 2010 and the performance audit conducted by the Australian National Audit Organisation (ANAO) in 2011 a high number of complementary medicine non-compliance were identified. To address the recommendations given in the Auditor-General’s report and the results of informal working group review the Secretary of Department of Health and Ageing (DoHA) published ‘TGA Reforms: A Blueprint for TGA’s Future’ which one of its reforms is associated with complementary medicines. The complementary medicine reforms consist of seven aspects and are aimed to reduce the level of non-compliance by sponsors. These changes to complementary medicines regulatory framework are most likely to have impact on the industry and the consumer which include better understand of the current Australian guidelines on complementary medicines, sponsors are encouraged to continuously comply with the regulatory requirements, more informed consumer in regards to complementary medicines and the increased protection of consumer from misleading indications.

1. Introduction 1.1Background

There are 10000 complementary medicines supplied in Australian market and only about 200 of them are registered on the Australian Register of Therapeutic Goods (ARTG). The remaining numbers of complementary medicines are listed on the ARTG. This proportion of registered and listed complementary medicines (98%:2%) might be the result of easy and low cost of listing products compare to registering

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Lina Karlina (2067226) Page 7_of25 which normally slow, high cost and demands more and strict requirements e.g. clinical trial documents.

According to the National institute of Complementary Medicine (NICM), at least two out of three Australians use Complementary Medicine (CM) and in the period of 2010-2011 Australians spent more expenses on CM ($2 billion) compare to conventional medicine e.g. prescribed medicines, over the counter medicines ($1.6 billion) (NICM, 2014).

A survey conducted in November 2013 to January 2014 shows that the Australian complementary industry is healthy and growing with significant growth estimation in 2017-2018 ($4.6 billion revenue, increase to 45,000 employees). The increasing use of complementary medicines in Australia is probably due to several factors as follows (NICM, 2014):

 The search for substitute of conventional medicines with less adverse effects.  Many consumers view complementary medicines as natural and considered as

risk-free (no adverse effects) or at least safer compare to conventional medicines. However, there is no risk-free therapeutic product including complementary medicine even it is listed on the ARTG that considered low–risk complementary medicines.

 There are potential risks pose by prolonged use of some conventional medicines  Relatively lower cost than conventional medicines especially prescribed

medicines

 The increased number of chronic disease, elderly

Complementary medicines supplied in Australian market are regulated by the TGA and must be either listed or registered on the Australian Registration of Therapeutic Goods (ARTG). Only complementary medicines contain ingredients permitted in low

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Lina Karlina (2067226) Page 8_of25 risk medicines can be listed on the ARTG. The listing can be conducted by pre-market self-assessment scheme through the Electronic Listing Facility (ELF). Therefore, the products are not evaluated by the TGA for its safety, quality and efficacy before entering the market. However, the ELF system ensures that the products only contain permitted (safe) substances for low risk products and are manufactured in GMP licensed facility (Harvey, 2008). The self-assessment method is highly depends on trust on the complementary sponsor. Nevertheless, the scope of post-market monitoring by the TGA covers all medicines regardless its registration scheme (listed or registered).

Complementary medicines started to draw attention to its stakeholders including regulatory authority, industry and consumers due to two major incidences. The first incidence occurred in 2003 when the Pan Pharmaceuticals recalled more than 1600 of its complementary medicine products. The second incidence occurred in 2010 when the Department of Health and Ageing (DoHA) released a result of post-market compliance review conducted by TGA on complementary medicines. It is reported that 90% of the reviewed complementary medicines were non-compliant with regulatory requirements which partially required removal from the ARTG and only 3 products were compliant (DoHA, 2011).

Given the two major incidences, an audit was conducted in August 2011 by the Australian National Audit Organisation (ANAO) as part of periodic audit on TGA’s performance was focused on listed complementary medicines. As a response, in December 2011 the DoHA published several reforms compiled in the ‘TGA Reforms: A Blueprint for TGA’s Future’ which one of its reforms is related to complementary medicines. The purpose of these reforms on complementary medicines is to reduce the level of non-compliance by sponsors. In this reforms project the TGA holds a major role in planning, implementing, monitoring and evaluating the results.

This research is intended to describe the changes in complementary medicines regulations that the Therapeutic Goods Administration (TGA) have planned.

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Lina Karlina (2067226) Page 9_of25 Additionally, it will also describe potential impact of the changes on complementary medicines industry and consumers.

1.2Purpose

The purpose of this research is to describe the impact of the TGA reforms on complementary medicines to the industry and consumers

2. Literature Review

2.1 Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is an Australian government institution under the Department of Health and Ageing that has the responsibility to regulate therapeutic goods supplied in Australia including the evaluation of its quality, safety and efficacy. These therapeutic goods comprise prescription medicines, over-the-counter medicines, medical devices and complementary medicines. The scope of its regulatory control would include the supply, manufacturing and advertising of therapeutic goods (TGA, 2014).

During a product life cycle the TGA is responsible for the pre-market assessment, post-market monitoring and licensing of its Australian manufacturers. In spite of how the therapeutic goods are approved for sale, either as Aust L or Aust R, it is subjected to post market monitoring once it has listed or registered on the Australian Register of Therapeutic Goods (ARTG) (TGA, 2014).

TGA post market regulatory activity of complementary medicines consists of the following elements (TGA, 2014; NICM, 2014):

 inspection of manufacturers for compliance with Good Manufacturing Practice (GMP)

 compliance review for listed complementary medicines  monitoring if adverse reactions to complementary medicines

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Lina Karlina (2067226) Page 10_of25  laboratory testing of complementary medicines in forms of products and

ingredients

 surveillance in the market place

 control and monitoring of complementary medicines advertising

2.2 Complementary Medicines

According to the Therapeutic Goods Regulations 1990, a complementary medicine is defined as a therapeutic good consisting principally of one or more designated active ingredients mentioned in Schedule 14 of the Regulations, each of which has a clearly established identity and traditional use (TGA, 2014)

In Australia, complementary medicines would include vitamins, minerals, herbals, nutritional supplements, certain aromatherapy preparations and homoeopathic products. In relation to regulatory framework, complementary medicines are classified into two types based on its potential risks to consumers, these are (TGA, 2014):

 Low-risk complementary medicines, can be listed on the ARTG  High-risk complementary medicines, must be registered on the ARTG

Complementary medicines are regulated under the Australian Regulatory Guidelines for Complementary Medicines (ARGCM). It contains regulatory requirements that complementary medicines sponsors are bound to comply with.

The risk profiles of complementary medicines are established based on the following elements (TGA, 2014):

 The composition of substances in the product

 The potential in resulting adverse effects either from short-term or long-term use or due to inappropriate administration.

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Lina Karlina (2067226) Page 11_of25 Product risk is inherent in therapeutic goods including complementary medicines. However, the risks are acceptable when the benefits outweigh the risks. Risks that may be occurring in respect to the use of complementary medicines are as follows (Harvey, 2008; NICM, 2014):

 Adverse reaction

 Drug interaction when consumed together with some conventional medicines  Use a complementary medicine to replace clinically proven treatment

Sponsors are not allowed to make indications and claims for listed complementary medicines other than for health maintenance, health improvement and treatment of non-serious illness.

There are certain information that the labels of complementary medicines required to have which include (NICM, 2014):

 Product name

 Name and quantities of ingredients

 Name of ingredients that are known to present a risk to some consumers

 Dosage form

 Quantity of the medicine  Required warning statements  Directions for use

 Name and address of the sponsor  Indications/claims

 Registration/listing number

3. Methodology

Method that will be used in this research is qualitative research method to analyse data/information gathered through relevant literatures.

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Lina Karlina (2067226) Page 12_of25 4. Discussion

4.1Complementary Medicines Reforms

Reforms in regards to complementary medicines are part of the “TGA reforms: A blueprint for TGA’s future” which was raised by The Secretary of Department of Health and Ageing (DoHA) in December 2011. The ‘TGA reforms: A blueprint for TGA’s future’ was published as a response to several major reviews in therapeutic goods regulations carried out by government institutions and informal working groups in 2010 and 2011. Among those reviews there were two reviews that are directly related to complementary medicines. The first review is the Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines that was released on 30 August 2011 as a result of performance audit conducted by the Australian National Audit Office (ANAO) in the same year. The second review is when an informal working group was examining the complementary medicines regulation and causes of low percentage of regulatory compliance.

The diagram below shows a simple process map that describes how the complementary medicine reforms were finally released.

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Lina Karlina (2067226) Page 13_of25 Picture 1. Process map of complementary medicines reforms

8 December 2011: TGA Reforms: A Blueprint for TGA’s future

These reforms are grouped under the following themes:

 Communications and stakeholder engagement

 Advertising of therapeutic products

 Complementary medicines (Complementary Medicine Reforms)

 Medical devices

 Promotion of therapeutic products

Major reviews of therapeutic goods regulations in 2010 & 2011:

 The review to improve the transparency of the TGA

 Public consultations on the regulatory framework for advertising therapeutic goods

 The Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines (August 2011)

 An informal working group examining the regulation of

complementary medicines and reasons for low compliance rates

 Public consultations on the medical devices regulatory framework

 The Working Group on Promotion of Therapeutic Products

 The Health Technology Assessment Review

 The Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines (August 2011)

Resulted 5 recommendations  An informal working group

examining the regulation of complementary medicines and reasons for low compliance rates

Resulted 6 recommendations

Complementary Medicines Reforms

(Addresses the above 2 reviews in respect to complementary medicines: Auditor-General’s report and Informal Working Group)

 Update to the Australian Regulatory Guidelines for Complementary Medicines

 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines

 Update to the listed medicines electronic application portal

 Enhancing post-market monitoring

 Publishing outcomes of listing compliance reviews

 Permitted (coded) indications project

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Lina Karlina (2067226) Page 14_of25 As mentioned in the above diagram the Complementary Medicines Reforms include seven aspects that will be described in the following discussion (TGA, 2014).

4.1.1 Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

This reform is a response to the Auditor-General’s report particularly on one of its findings which is that the TGA has taken and continues to take a long time in reviewing guidance documentation for complementary medicines (ANAO, 2011). This situation may cause precariousness on how to comply with the regulatory requirements. Moreover, currency is an important nature of regulatory guidance which will affect the regulator on how to respond on findings.

Therefore, the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) as one of the primary guidelines that regulate complementary medicines is updated by the TGA in a timely manner through the following activities (DoHA, 2011):

 Publish completion date for the update of ARGCM

 Provide periodic reports of progress on the current updates include its publication on the TGA website.

4.1.2 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines

One of the recommendations from Informal Working Group review is to update the ‘Guidelines for levels and kinds of evidence to support indications and claims’ which was published on April 2011. In order to address the recommendation the TGA has replaced it with the ‘Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines’ which was published on March 2014 and refined on July 2014. The revision of previous guidelines was conducted through public consultation with the stakeholders to accommodate their opinions and to ensure

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Lina Karlina (2067226) Page 15_of25 that the guidelines stay current and applicable with present situation (DoHA, 2011).

4.1.3 Update to the listed medicines electronic application portal

In the Auditor-General’s report it was recommended that the TGA enhance the integrity of listing procedure of complementary medicines due to the increased number of inappropriate use of free-text field on the electronic system by sponsors. This reform on the electronic application portal is aimed to ensure that only permitted claims or indications are made by the sponsors for their complementary medicines. To achieve this purpose the TGA has planned to remove the free-text field from the electronic application portal. By doing so the TGA has directed the sponsors to use only the permitted list of indications available on the portal (DoHA, 2011).

4.1.4 Enhancing post-market monitoring

Based on the performance audit conducted by the ANAO in 2011 apparently the TGA did not utilise the results of compliance review on listed complementary medicines for further use. Therefore, the TGA was recommended to use the results of compliance review in generating risk profiles on sponsors and complementary medicines which later will provide a tool in determining priority of targeted post-market reviews (ANAO, 2011). This reform in post-market monitoring program is carried out to improve the compliance rate with the existing regulatory framework of complementary medicines. The TGA has agreed to the recommendation made by the ANAO by implementing a risk-based approach in the conduct of its post-market reviews (DoHA, 2011).

4.1.5 Publishing outcomes of listing compliance reviews

According to the ANAO findings the TGA has not publicise the results of its listing compliance reviews despite the fact that the review has been conducted

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Lina Karlina (2067226) Page 16_of25 for a long time and that those results are considered important information for consumers in selecting complementary medicines to be used. Nevertheless, the TGA has always announced review outcomes which may result in adverse reaction and/or product recall (ANAO, 2011).

In order to provide information associated with listing compliance review to consumers the TGA will make the information available to public through the provision of publicly-viewable elements on the ARTG. This information will include the complementary medicines that have been reviewed as part of the post-market monitoring program as well as the review outcomes (DoHA, 2011).

4.1.6 Permitted (coded) indications project

The trigger for this reform associated with permitted indications project is the increased rate of inappropriate claims made about listed complementary medicines by the sponsors. This reform is closely related to the previous reform which is ‘Update to the listed medicines electronic application portal’ (section 4.1.3) since it has the same reason and purpose for the reforms to be taken (ANAO, 2011).

Accordingly, the TGA will improve the permitted indications for listed complementary medicines through addition of new indications obtained from the evaluation of claims frequently made by sponsors in the free-text field on the ARTG (DoHA, 2011).

4.1.7 Investigation process for advertising breaches

Great number of breaches in complementary medicine advertising such as prohibited terms use and unpermitted claims are currently exist in many media including a widely used media, internet. The TGA holds a major responsibility in managing advertising breaches compared to other national agencies associated with advertising e.g., the Therapeutics Goods Advertising Code Council (TGACC) and the Complaints Resolution Panel (CRP). It was identified that the TGA did not specify a timeframe to complete investigations

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Lina Karlina (2067226) Page 17_of25 of advertising violations which resulted in two recommendations (ANAO, 2011).

To address the finding and recommendations the TGA have planned a number of measures in order to improve the investigation process for advertising violations which include (DoHA, 2011):

 Implementation of standard operating procedure for investigating advertising breaches

 Development of timeframes to complete investigations of advertising breaches

 Periodic reporting of the investigation progress to the TGA Executive It is planned to take four years for the Blueprint reforms to be completely implemented. This four years implementation period is divided into 3 phases as follows (TGA, 2012):

 Phase 1 (January – June 2012): better managing our communication  Phase 2 (July 2012 – June 2013): better managing our practice

 Phase 3 (July 2013 – December 2015): mature and sustainable performance Based on the Blueprint Implementation Schedule the implementation of complementary medicine reforms is scheduled to finish in phase 2 with the following details:

Table 1. Implementation schedule of complementary medicines reforms Work Streams Phase 1 – January 2012

to June 2012

Phase 2 – July 2012 to June 2013

Complementary Medicines

 Publication of key guidance documents

 Improved guidelines and information  Post market compliance reforms  Procedures for investigating

advertising breaches

Source: TGA, Delivering Reforms – Implementation plan for TGA Reforms: A blueprint for TGA’s future

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Lina Karlina (2067226) Page 18_of25 4.2Impact of Complementary Medicines Reforms to the Industry and the

Consumers

The impact of complementary medicine reforms on the industry and its consumers will be discussed according to each reform as described below.

4.2.1 Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

To the industry:

It is more likely to increase the compliance rate of complementary industry to the regulatory requirements since the updated guidelines represent the current regulatory framework. The probability of increase of compliance rate is also supported by the consultation process held after the first updated version of this guideline was published involving the TGA and the complementary medicine stakeholders to maintain the pertinence and currency of information available in the guidelines (DoHA, 2011).

To the consumer:

The higher the industry compliance rate to regulatory requirements the higher assurance that their products are safe and of good quality. Provided with the assurance that complementary medicines available in market place are safe and of good quality, it will result in higher consumer confidence in using complementary medicines which later may cause the increase of complementary medicines usage.

4.2.2 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines

To the industry:

The evidence guidelines describe the types and levels of evidence required to have to support claims or indication made by sponsors for their listed medicines

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Lina Karlina (2067226) Page 19_of25 including complementary medicines. By revising the previous guidelines to ensure the currency of information contained the sponsors will be more well-informed on the requirements demanded by the regulator and eventually it will likely increase the compliance rate to the regulatory requirements particularly when the TGA conducts its listing compliance review.

In spite of the positive impact, this reform on the evidence guidelines renders difficult some of the small industry of complementary medicines since it normally lack of resources to perform pre-clinical or clinical trial (CMA, 2014). To the consumer:

Claims or indications made about complementary medicines provided with scientifically sound evidence will increase the trust of consumers on the safety, quality and efficacy of complementary medicines because it is scientifically proven rather than just traditionally known to be effective for certain symptoms.

4.2.3 Update to the listed medicines electronic application portal

To the industry:

This reform is performed by eliminating the free-text field on the application portal which will direct the sponsors to use only the available indications provided by the TGA. These indications have been assessed and permitted to be used for low risk medicines such as listed complementary medicines. Therefore, it will limit the sponsors’ freedom in making claims and indications for their products which this can be considered as an advantage when the sponsor deliberately misuses the free-text field to make misleading or unsubstantiated claims or indications for promotion purposes. Moreover, it will be difficult for the sponsors to make particular indications that are not available in the list but considered as appropriate for low risk products. Given the situation, the sponsor can request for the new indications to be added to the list. However, the

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Lina Karlina (2067226) Page 20_of25 procedure would not be simple since it has to pass through assessment and regulation amendments (DoHA, 2011).

To the consumer:

Consumer will be more protected from misleading and unsubstantiated claims and indications. This is crucial especially when the sponsors do not hold evidence to support the safety of their products.

4.2.4 Enhancing post-market monitoring

To the industry:

Since a risk-based approach will be implemented on the TGA’s post-market monitoring program through the utilisation of risk profiles of sponsors and products characteristics which means products that pose high probability of non-compliant and sponsors who frequently innon-compliant will be more often subjected to post-market monitoring (Harvey, 2012). Therefore, this reform encourages the industry to continuously comply with regulatory requirements. To the consumer:

This will provide greater assurance to consumer that the listed complementary medicines reviewed by the TGA are proven to be safe, manufactured in GMP licensed facility, of good quality and effective. On the other hand, consumer may become unsure in regards to the safety, quality and efficacy of listed complementary medicines that have not been reviewed since post-market monitoring is performed only on a small percentage of the medicines.

4.2.5 Publishing outcomes of listing compliance reviews

To the industry:

Providing the results of listing compliance reviews to public through the TGA website resulted in positive and negative impact to the industry. The publication

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Lina Karlina (2067226) Page 21_of25 may be considered as free promotion media by notifying the public that their products have been reviewed and passed all the regulatory requirements. Nevertheless, it results in different situation when the products did not pass the review. Moreover, the company’s reputation may be damaged when the companies were given sanctions or financial penalties by the TGA and the medicine reviewed or other medicines produced by the company may be in questioned by consumer in regards to its safety, quality and efficacy. Consumer may question the safety, quality and efficacy of the product reviewed even if the product was only incompliant with some aspects of the regulatory requirements. To the consumer:

Publication of the outcomes of listing compliance reviews on the TGA website provides easy access for consumer to obtain information on complementary medicines that have been reviewed as well as the outcomes which will greatly assist the consumer in making well-informed decision associated with complementary medicines use.

4.2.6 Permitted (coded) indications project

This measure will be taken to support the previous action planned by the TGA which is the update to the listed medicines electronic application portal. Therefore, the impact are more likely to be similar.

To the industry:

The sponsors are only allowed to use indications permitted in the list which have been assessed by the TGA. This project limits the sponsors that previously used the free-text field to deliberately make misleading claims and indications for commercial purposes (Harvey, 2012).

To the consumer:

The indications available on the label of complementary medicines packaging would be those permitted by the TGA and appropriate for low risk medicines.

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Lina Karlina (2067226) Page 22_of25 Accordingly, it will prevent the consumers from being exposed to misleading and inappropriate indications.

4.2.7 Investigation process for advertising breaches

To the industry:

A risk-based approach will also be implemented in the investigation of advertising violations where risk profiles will be developed and trends will be made based on previous or historical data of advertising breaches (DoHA, 2011). Through trending of the breaches it will be easier to identify sponsors that often conducted violation on advertising as well as the common type of advertising breaches. In this regard, sponsors required to better understand and will be more aware of regulations and requirements applied to advertising of complementary medicines.

The development of investigation timeframes by the TGA will affect the response time to address complaint associated with violation in advertising as well as the time required to determine follow-up action (e.g. sanctions, financial penalties) to the sponsor who conducted the breaches.

To the consumer:

The completion of investigation associated with advertising breaches within specified timeframes ensures that follow up action in regard to the advertisement (e.g. withdrawal from media or public spaces) will be promptly carried out. It is necessary to have a fast response to prevent the more widespread of misleading information contained in the advertisement to a larger population.

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Lina Karlina (2067226) Page 23_of25 5. Conclusion and Recommendation

5.1Conclusion

 The complementary medicine reforms consist of the following elements:

- Update to the Australian Regulatory Guidelines for Complementary Medicines

- Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines

- Update to the listed medicines electronic application portal - Enhancing post-market monitoring

- Publishing outcomes of listing compliance reviews - Permitted (coded) indications project

- Investigation processes for advertising breaches  The impact of the reforms to the industry would include:

- The sponsors became better understand the Australian guidelines for complementary medicines (e.g. ARGCM, Evidence guideline) as well as the approach to comply with current regulatory framework.

- The sponsors are more encouraged to continuously comply with the regulatory requirements.

- The sponsors are limited to use only the permitted indications during listing of complementary medicines through the Electronic Listing Facility (ELF).  The impact of the reforms to the consumer would include:

- The consumer became more informed on complementary medicines that have been reviewed for compliance

- The increased consumer’s assurance that the complementary medicines supplied in the market place are safe and of good quality.

- The increased protection of consumer from misleading, inappropriate or unsubstantiated indications made for complementary medicines.

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Lina Karlina (2067226) Page 24_of25 5.2Recommendation

It is recommended that the government:

 Provides more incentives to encourage the industry to comply with the regulatory framework of complementary medicines.

 Accommodates the industry to conduct clinical research in complementary medicines to encourage evidence-based complementary medicines

 Provides basic information especially associated with listed complementary medicines in an interesting way to educate consumer as well as to assist in informed decision making.

 Applies more enhanced sanctions and financial penalties to advertising breaches.

References

ANAO, 2011, The Auditor – General audit Report No. 3 2011 – 12 Performance Audit Therapeutic Goods Regulation: Complementary Medicine, Australia.

CMA, 2014, 2014 Complementary Medicines Industry Survey, Australia

DoHA, 2011, TGA Reforms: A Blueprint for TGA’s Future, Australia. Harvey, K, 2008, Does CM regulation need reform?, Australia.

Harvey, K, 2012, TGA Complementary Medicines Reforms, Australia.

NICM, 2014, The Safety of Complementary Medicines, Australia.

NICM, 2014, Information for Consumers: Reports, Surveys and Audits, Australia. <http://www.nicm.edu.au/health_information/information_for_consumers/reports,_ surveys,_audits>

TGA, 2012, Delivering Reforms – Implementation Plan for TGA Reforms: A Blueprint for TGA’s Future, Australia.

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Lina Karlina (2067226) Page 25_of25 <http://www.tga.gov.au/complementary-medicine-regulation-basics>

TGA, 2014, Complementary Medicines Reforms, Australia.

< http://www.tga.gov.au/complementary-medicines-reforms> TGA, 2014, TGA Basics, Australia. <http://www.tga.gov.au/tga-basics>

Bibliography

Bollen, D & Whicker, S, 2009, Complementary Medicines Regulatory Reform, Australian ‘Health Review’, Vol. 33, No. 2, Australia.

Harvey, K, 2008, Australian Complementary Medicine Regulation: Time for Reform!, ‘Health Issues’, Winter 2008, Issue 95, Australia.

Harvey, K, 2009, A Review of Proposals to Reform the Regulation of Complementary Medicines, ‘Australian Health Review’, Vol. 33, No. 2, Australia.

Harvey, K, 2012, The Evidence for Complementary Medicines, ‘Consumers Health Forum of Australia’, Issue 11, Australia.

Pollard et.al., 2008, Commercialism, Choice and Consumer Protection: Regulation of Complementary Medicines in Australia, ‘MJA’, Vol. 1889, No. 1, Australia.

Wardle, J, et.al., 2014, Regulatory and Legislative Protections for Consumers in Complementary Medicine: Lessons from Australian Policy and Legal Development, ‘European Journal of Integrative Medicine’, Australia.

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Lina Karlina (2067226) Page 20_of25 procedure would not be simple since it has to pass through assessment and regulation amendments (DoHA, 2011).

To the consumer:

Consumer will be more protected from misleading and unsubstantiated claims and indications. This is crucial especially when the sponsors do not hold evidence to support the safety of their products.

4.2.4 Enhancing post-market monitoring To the industry:

4.2.5 Publishing outcomes of listing compliance reviews To the industry:

Providing the results of listing compliance reviews to public through the TGA website resulted in positive and negative impact to the industry. The publication

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4.2.6 Permitted (coded) indications project

To the industry:

To the consumer:

The indications available on the label of complementary medicines packaging would be those permitted by the TGA and appropriate for low risk medicines.

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Lina Karlina (2067226) Page 22_of25 Accordingly, it will prevent the consumers from being exposed to misleading and inappropriate indications.

4.2.7 Investigation process for advertising breaches To the industry: