RE: CALL FOR SUBMISSIONS – COMPLEMENTARY ...

Rhiannon Bandiera PhD Candidate School of Law Flinders University GPO Box 2100 Adelaide SA 5001 Tel: 08 8201 3706 Fax: 08 8201 3630 [email protected] http://www.flinders.edu.au/ehl/law/ CRICOS Provider No. 00114A

8 April 2015 Review of Medicines and Medical Devices Regulation Secretariat Department of Health MDP 67 GPO Box 9848 Canberra ACT 2601

RE: CALL FOR SUBMISSIONS – COMPLEMENTARY MEDICINES Dear Sir/Madam, I wish to submit my comments in response to the Australian Department of Health’s Expert Review of Medicines and Medical Devices Regulation – Complementary Medicines. The recommendations outlined in this document are based on the findings of my PhD thesis research which will be due for submission in 2016, with the current title: “By-products of responsive governance: Regulatory compliance in the Australian pharmaceutical industry”. This submission offers a disciplined response to the regulation of medicines and medical devices from the field of criminology. In this document, an overview is provided of the PhD research study and its initial findings. The research involves an analysis of the post-market enforcement activities of the TGA, in areas such as GMP, and advertising and promotion, to determine how certain regulatory strategies might affect corporate compliance with regulations. It looks to establish how compliance risks are managed within the Australian pharmaceutical market, how such strategies are received by businesses, and the overall impact of such strategies on business behaviour. This analysis is approached through the conceptual framework of “responsive regulation”, a theory which has had substantial influence on corporate law and regulatory policy in Australia. The submission provides responses to the review questions under Themes 2, 3 and 4 in light of these research findings. A thematic concept map which depicts the themes arising from the analysed data has been provided with this submission as a separate attachment. I thank you for the opportunity to provide a submission to the Expert Review. I am available to provide further clarification on the points raised if required. I wish you well in your deliberation. Kind regards, Rhiannon Bandiera, BBSc Hons PhD Candidate

ABSTRACT The recommendations detailed in this submission are based on the findings of my PhD thesis research which will be due for submission in 2016, with the current provisional title: “By-products of responsive governance: Regulatory compliance in the Australian pharmaceutical industry”. This submission offers a disciplined response to the review, approaching the regulation of medicines and medical devices from the field of criminology. The findings suggest that there are numerous sources of failure inherent within the current regulatory regime which result in regulation deficiency. There are a number of areas in which the implementation of regulation is inadequate (implementation failure) and where enforcement measures lack the adequate strength to compel compliance (instrument failure). Aspects of the self-regulatory regime were found to be unenforceable and inadequate for deterring misconduct (self-regulation or private law failure). The TGA has also had a history of failing to provide adequate information to all stakeholders, specifically the general public (information failure). Combined with the lack of and need for procedural transparency, the lack of information access had led the TGA to become largely unaccountable to its stakeholders and the general public, which in turn has resulted in stakeholder perceptions of bias and clientism.

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OVERVIEW OF RECOMMENDATIONS 1. Existing enforcement measures need to be enhanced to create greater incentive for businesses to comply with the regime. a. Financial penalties should be made available to the CRP should businesses fail to comply with initial determinations. b. Financial penalties should be increased within the Therapeutic Goods Act 1989 to make legislated enforcement action more feasible. 2. For enforcement to be successful in deterring regulatory non-compliance, regulatory action must be enforceable and form part of a larger graduated enforcement strategy. 3. Mechanisms, such as mandatory adherence to a single, principles-based code of conduct, should be implemented to minimise the prospect of law evasion. 4. The regime must be more responsive to forms of risk beyond those risks which are simply inherent to the product (compliance risks). 5. The recommendations of the permitted coded indications project should be implemented to reduce the capacity for sponsors to include inappropriate information on the ARTG. 6. All sponsors should be made to supply evidence supporting product indications upon listing. 7. Without first addressing existing regulatory failures, such as the lack of enforceability and deterrent effect of the current co-regulatory and self-regulatory regimes, a self-regulatory and/or co-regulatory pre-vetting or pre-approval scheme will continue to be exploited. a. If pre-approval were to be applied, it should be standardised. b. Should standardised pre-approval be infeasible, consideration should be given to placing mandatory disclaimers on product packaging to reflect the true regulatory status of the product, and to the development of a voluntary pre-approval scheme. 8. The regulation of complementary and low-risk listed medicines should maintained under pre-existing legislative frameworks—more of an emphasis should be placed on enhancing those aspects of the Act which currently make legal action against non-compliant businesses infeasible. 9. A complementary medicines (or listed medicines) GMP guideline should be developed. 10. An overarching principles-based code and a centralised complaints body to cover all therapeutic goods should be created. 11. Further information regarding TGA enforcement actions should be publicised on the TGA website, specifically the reasoning behind product cancellations and suspensions. The evolution and benchmarking of the above points is recommended for future reviews.

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TABLE OF CONTENTS Abstract ...........................................................................................................................................i Overview of Recommendations ......................................................................................................ii Introduction .....................................................................................................................................1 Outline of the Study ........................................................................................................................1 Overview of the Findings................................................................................................................2 Responses to the Review Questions ...............................................................................................4 Theme 4: Inadequate Deterrents .........................................................................................4 Theme 2: Regulatory Requirements are not Commensurate with Risk ..............................9 Issue 1 – Interface between complementary medicines and pharmaceuticals .......9 Issue 4 – Evidence requirements.............................................................................10 Issue 6 – Pre-publication for advertising ...............................................................13 Issues 1, 2 & 3 .........................................................................................................14 Issue 5 – Compliance with GMP ............................................................................15 Theme 3: Complex Regulatory Framework .......................................................................16 Issue 1 – Lack of understanding of the requirements for listing.............................16 Issue 2 – Poor consumer understanding .................................................................18 Summary .........................................................................................................................................19 Reference List .................................................................................................................................21

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Submission: Expert Review of Medicines and Medical Devices Regulation – Complementary Medicines Rhiannon Bandiera PhD Candidate Flinders University Law School INTRODUCTION I welcome the opportunity to provide a submission to the Australian Department of Health’s Expert Review of Medicines and Medical Devices Regulation – Complementary Medicines. The recommendations detailed in this submission are based on the findings of my PhD thesis research which will be due for submission in 2016, current provisional title: “By-products of responsive governance: Regulatory compliance in the Australian pharmaceutical industry”1. This submission offers a discipline-specific response to the review, approaching the regulation of medicines and medical devices from the field of criminology. In this submission, an overview of the PhD research study is provided, as well as a brief overview of the research findings. The submission will then provide responses to the review questions in the following order, since this order is in line with my research findings:  Theme 4: Inadequate Deterrents  Theme 2: Regulatory Requirements are not Commensurate with Risk o Issue 1 – Interface between complementary medicines and pharmaceuticals o Issue 4 – Evidence requirements o Issue 6 – Pre-publication for advertising o Issues 1, 2 & 3  Should complementary medicines be regulated under a separate framework?  Should low-risk complementary medicines be regulated as general consumer goods?  Should certain dietary supplements be regulated as foods? o Issue 5 – Compliance with GMP  Theme 3: Complex Regulatory Framework o Issue 1 – Lack of understanding of the requirements for listing o Issue 2 – Poor consumer understanding OUTLINE OF THE STUDY My research involves an investigation into the post-market enforcement activities of the Therapeutic Goods Administration (TGA), in areas such as good manufacturing practice, and advertising and promotion, to determine how certain regulatory strategies might affect corporate compliance with regulations. It looks to establish how compliance risks are managed within the 1

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Australian pharmaceutical market, how such strategies are received by businesses, and the overall impact of such strategies on business behaviour. This analysis of TGA enforcement has been approached through the conceptual framework of “responsive regulation”, a theory developed by economist Ian Ayres and criminologist John Braithwaite in 1992, which has had substantial influence on corporate law and regulatory policy in Australia (Parliament of Australia 2014). The scope of this PhD is restricted to the regulation of Australian medicines industry, namely the complementary, over-the-counter and prescription medicines sectors. Due to the lack of public reporting of TGA enforcement outcomes, along with the commercial sensitivities associated with the release of such information, this PhD has utilised a qualitative research approach to evaluate the extent of TGA post-market regulatory enforcement. Data for this project was obtained from two sources: from consultation submissions to TGA, Government, and Parliamentary Reviews which aimed to reform the post-market regulation of medicines; and from semi-structured interviews with individuals connected to the regulatory process. 12 consultations listed on the TGA, Department of Health, and Parliament of Australia websites between the 27th of August, 2010 (the end date for submissions to the consultation Improving Advertising Arrangements for Therapeutic Goods) and 30th of June, 2014 were selected as part of this analysis2. Interview participants comprised of current and former TGA staff, representatives from industry associations, academics, consumer groups, and legal aids. The views of industry were well represented in the number of submissions made to the consultations being analysed. A thematic analysis of interview transcripts and public consultation submissions was used to identify, report and analyse commonly occurring patterns (themes) from the data with respect to individual and organisational perceptions towards the TGA and its responsiveness to corporate noncompliance. OVERVIEW OF FINDINGS Some of the themes that were identified from the data are depicted in Figure 1, which has been supplied as a separate attachment3. It is important to reinforce here that as the PhD has not yet been submitted for examination, these results should be treated as preliminary (unpublished) findings. The map that has been provided is also an adaptation of the final version that will be used in the PhD thesis, which I am prepared to submit in 2016. Although the majority of consultations and their submissions were in response to the regulation and reform of the complementary medicines sectors, the findings are also true (generalisable) for the over-the-counter and prescription medicines sectors. Overall, the findings suggest that there are numerous sources of failure inherent within the current regulatory regime which result in regulation deficiency. The vast majority of themes reflect upon the perceived effectiveness of government intervention and suggest that there are a number of areas in which the implementation of regulation is inadequate (implementation failure). These include perceptions of regulatory action as being largely unenforceable, failing to have a deterrent effect, and sometimes absent, slow to respond, and largely reactive. Structural limitations to the 2

All consultations listed on these websites during this period were considered to reflect the current responses and attitudes towards the regulatory regime. 3 It is recommended that Attachment One is printed in A3 size for best results.

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regime, such as the broadness of regulatory scope, the fragmented nature of the regime, and the effects of current legal and appeals processes, were also sources for implementation failure. This led many stakeholders to argue that industry were largely under-regulated and that the regime therefore lacked adequate strength (instrument failure). Self-regulation (private law) as an alternative to government regulation also suffered from many similar failings according to stakeholders and interviewees (self-regulation or private law failures). Self-regulation was also perceived to be unenforceable and inadequate for deterring misconduct. The self-regulatory regime was also reported as being largely fragmented, prompting calls for enforcement and complaints processes to be centralised. The TGA has also had a history of failing to provide adequate information to all stakeholders, specifically the general public (information failure). Legal barriers prevented the TGA from disseminating information, and the technicality of information, lack of access to independent sources of information, and the inconsistency of information provision, impacted upon consumer health literacy and understanding of the regulatory process. Combined with the lack of procedural transparency, the lack of information access had led the TGA to become largely unaccountable to its stakeholders and the general public, which in turn has resulted in stakeholder perceptions of bias and clientism. Combined, these regulatory failures have led to the development of regulation deficiency, where the government has passively facilitated, despite good intentions, the harms associated with industry non-compliance4 (Griffin & Miller 2011).

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I am prepared to provide a further explanation of these points if required.

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RESPONSES TO REVIEW QUESTIONS THEME 4: INADEQUATE DETERRENTS 1. Does the current legislative framework provide sufficient deterrents to prevent sponsors from knowingly listing non‐compliant complementary medicines on the ARTG? If not, what additional measures should be considered? 2. Should complementary medicines that are withdrawn from the ARTG require some form of assessment before being able to be re‐listed? 3. How effective are the current post‐market compliance reviews of complementary medicines in minimising exposure of consumers to non‐compliant complementary medicines? It was largely perceived by stakeholders that regulatory action has failed to have a deterrent effect on corporate non-compliance in the area of complementary medicines. The range and severity of punishments for example, has been widely reported as having provided little inventive for businesses to comply. Regulatory action is also largely unenforceable; companies can choose to not comply with sanctions and determinations, and can do so without penalty, leaving administrative bodies unable to compel businesses to cooperate. This has led to the suggestion that a significant proportion of complementary medicines are found to have misleading labelling and ARTG information, and manufacturing and quality, and efficacy issues (Australian National Audit Office (ANAO) 2011). The TGA uses a graduated enforcement approach in response to corporate non-compliance, which remains relatively consistent even when responding to different compliance issues. The TGA will begin by using persuasive tactics and warnings, and will then escalate its response to listing suspension or cancellation, before threatening to resort to legal action against companies who continue to demonstrate non-compliance (see Table 1). Table 1: Graduated Enforcement Options for the TGA. Response Severity Persuasion

Deterrence

Following a Post-Market Compliance Review  Issue Notice under s. 30 of Therapeutic Goods Act 1989 (i.e. cancellation or proposal to cancel ARTG Listing).  Cancellation and/or Suspension of Listing from the ARTG, or product recall.  Threaten to refer matters onto Commonwealth Director of Public Prosecutions for legal action.

Following an Advertising Complaint Determination  Warning Letter.  Issue of a Regulation 9 Order (i.e. publication of a correctional notice and/or retraction of the advertisement).  Cancellation of Listing from the ARTG.  Threaten to refer matters onto Commonwealth Director of Public Prosecutions for legal action.

Adapted from information provided by TGA (2012b) and ANAO (2011).

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In some aspects of the regime, such as in advertising regulation, regulatory enforcement also operates at a co-regulatory and self-regulatory level, where additional levels of enforcement, such as correctional notices and monetary penalties, can also be applied. This submission will evaluate the deterrent effect of each of these responses to non-compliance, from the feasibility of compliance reviews, to the impact of correctional notices and retractions, and threats of product cancellation, monetary penalties and legal action. The Feasibility of Compliance Reviews According to the ANAO (2011), between 10 – 20% of newly listed medicines undergo a random or targeted compliance review once listed on the Australian Register for Therapeutic Goods (ARTG). However, the low rate of audit, relative to the amount of new products listed on the ARTG each year, has meant that the calculated risk of being caught by the TGA for noncompliance is low and as a result, the threat of a post-market compliance review fails to truly compel businesses to comply. As was indicated in submissions to the Transparency Review: [t]he ease and minimal cost of registering an L product means manufacturers can take the risk of registering multiple products which may never get picked up in random audits (Research Scientist, in the 2011 consultation Public Submissions to the TGA Transparency Review).

On occasion, products are voluntarily cancelled from the ARTG by the product sponsor upon receiving a request by the TGA to supply information for the purposes of a compliance review (ANAO 2011). The TGA has also had a history of ‘not verifying independently that corrective action has been taken’ and is thus reliant on sponsors to self-certify their compliance with the review’s outcomes (ANAO 2011, p. 99). Although most businesses will comply simply because it is the law, entrusting corrective action onto regulated entities without verifying whether any corrective action has taken place can leave the review system open to exploitation. This again leads the threat of a compliance review to be empty. Product Removal from the ARTG Threats to remove products from the ARTG also provides little disincentive for businesses due to the ease of re-applying to re-list substantially similar products and at a relatively low cost—in the hundreds of dollars range. Allegedly: [t]here is no pre-market scrutiny of the actual product specification, label, instructions, packaging, advertising or evidence of its efficacy.… Apart from a few yes/no questions aimed at classification, there is only a very small list of 'prohibited words' and a small 'restricted word' list that will trigger a review that can stop the application of any product being successful (Non-for-Profit Organisation, in the 2012 consultation Evidence Required to Support Indications for Listed Medicines 1).

Coupled with the low probability of the product undergoing a post-market review, the consequence, as was stated in the Review Document, has been a significant degree of law evasion and “gaming” of the system. Furthermore, complaints against products which have since been removed from the ARTG by the product’s sponsor are not pursued by the TGA (ANAO 2011). The current regime is therefore exploitable as businesses are able to avoid the application of punishment for non-compliant behaviour.

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The Impact of Warning Letters, Correctional Notices and Retractions In response to the effectiveness of the Complaints Resolution Panel (CRP) determinations, one stakeholder claimed: unless a restricted representation is made, advertising breaches are unlikely to receive a penalty any stronger than a notice to withdraw the advertisement and to not repeat the misdemeanour. Even in the worst cases, the strongest penalty imposed is a 180 day retraction…. by the time the CRP has made a determination, the run of the advertisement in specified media is complete. As such, a request to remove the representation and not repeat it within 12 months appears little disincentive to abide by the Therapeutic Goods Act and the TGAC (Industry Association 1, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods).

A separate submission to the same consultation stated that: [the] request to publish corrective advertising is a reflective measure which occurs after an offending advertisement has been exposed to the public and [when it has] most likely made some impact on consumers. Corrective advertisements are… issued in isolation to the offending material and therefore have minimal connection with the actual breach (Professional Body, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods).

Misleading claims can continue to be used whilst a case is being heard by the CRP, and, when cases are passed onto the TGA following a sponsor’s lack of compliance with a CRP determination (ANAO 2011). According to the ANAO (2011), it took an average of 183 days, or six months, for an advertiser to voluntarily rectify non-compliant advertising following the issue of numerous warning letters by the TGA5. Retractions which are published on the sponsor’s website may also lack the same reach as the medium in which the misleading advertising originally appeared. Consequently, CRP determinations have little financial or reputational impact on non-compliant businesses, and are therefore unlikely to generate compliance since it is not economically rational for businesses to do so. The Impact of Monetary Penalties Industry associations, unlike the TGA and CRP, make use of financial penalties for violations of the advertising regime. While penalties under self-regulatory schemes do operate on a “sliding scale”, meaning they can be increased or decreased according to offence severity, the maximum financial penalty at the apex of such self-regulatory schemes is $50,000—an amount which is reserved for repeat breaches of the self-regulatory code (Australian Self Medication Industry (ASMI) 2015). Many stakeholders have reported that such penalties have little impact on businesses financially, especially relative to the amount of profits the advertising of products generate. For those businesses which may be economically motivated, few financial incentives exist to compel compliance with the regime (especially when non-compliance appears more profitable) (Ayres & Braithwaite 1992). Lack of Enforceability of Sanctions Both co-regulatory and self-regulatory bodies also lack the capability to compel businesses to comply with administrative rulings and requests. 5

This estimate does not take into consideration the time that elapsed prior to the TGA taking action against the company.

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At present where an advertiser chooses not to comply with a sanction imposed by the TGAC the only recourse that the TGAC has available is to make a recommendation to the Secretary that the inclusion of the goods on the ARTG be cancelled…. as the sanctions are not enforceable, an advertiser making false and misleading claims can choose not to comply with the imposed sanctions, particularly where complying with such sanctions would be costly (Sponsor 1, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods).

The case of Reckitt Benckiser Australia and the promotion of “Nurofen” as a targeted pain reliever (TGA 2014) is a recent example which demonstrates the lack of enforceability behind administrative requests and rulings—the case has since been taken up by the Australian Competition and Consumer Commission (ACCC) after all avenues to generate compliance were exhausted by the TGA. Threats of Legal Action A full range of legal sanctions are available to the TGA under the Therapeutic Goods Act 1989 (the Act) when administrative requests fail to achieve compliance. However, it is believed that: [d]ue to the very low financial penalties currently available (a maximum of $6,600 for individuals and $33,000 for corporations) for advertising offences in the Act… it is not cost-effective for the TGA to initiate a formal investigation of an advertising breach with a view of preparing a brief of evidence for consideration of prosecution by the Director of Prosecutions…. It has never been cost-effective (ANAO 2011, pp. 130 – 131).

Civil and criminal penalties for failing to comply with administrative requests and penalties have never been successfully applied for advertising breaches by the TGA (ANAO 2011). As the full range of penalties are unable to be applied, the TGA lack the ability to escalate regulatory intervention (and ultimately, to compel compliance from regulated entities). In the area of self-regulation, businesses can also avoid having to comply with industry panel determinations by simply choosing not to be affiliated with one of the industry associations and its code of conduct. As there are no mechanisms to compel companies to adhere to an industry code, and again, no penalty for failing to adhere and/or recognise an industry code of conduct, selfregulation fails to compel businesses not affiliated with an industry association to comply with the regime. Theoretical Implications of a Lack of Responsive Regulation A responsive regulatory framework offers a dynamic approach to regulatory enforcement; ‘the regulator refrains form a deterrent response as long as the firm is co-operating; but when the firm yields to the temptation to exploit the cooperative posture of the regulator and cheats on compliance, then the regulator shifts from a cooperative to a deterrent response’ (Ayres & Braithwaite 1992, p. 21). This approach to regulation is envisaged in Ayres & Braithwaite’s “Enforcement Pyramid” (see Figure 2), where the degree of intervention by the regulator can be escalated or de-escalated through the levels of the pyramid in order to generate or reward compliant behaviour. A responsive regulatory regime primarily encompasses self-regulation, which occurs at the pyramid’s base, and then escalates to enforced self-regulation, and discretionary and nondiscretionary forms of punishment as businesses demonstrate greater non-compliance (Ayres & Braithwaite 1992). Regulators can first use lower-level, persuasive responses, such as warnings,

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warning letters and fines, to entice businesses to comply, and then progress to civil and criminal penalties, and license suspension and revocation should businesses continue to fail to cooperate (Ayres & Braithwaite 1992). By ‘maximizing the difference between the punishment payoff and the cooperation pay off, it makes cooperation the most economically rational response’ for businesses (Ayres & Braithwaite 1992, p. 26). Figure 2: The “Pyramid of Enforcement Strategies”, from Ayres & Braithwaite (1992, p. 39). Command Regulation with Non-discretionary punishment

Command Regulation with Discretionary punishment

Enforced Self-Regulation

Self-Regulation

Currently, however, the non-prescription medicines regime largely operates at the lower levels of the enforcement pyramid and regulatory action is unable to be escalated to more punitive, higherlevel responses. Therefore the threat of escalation is insufficient to induce compliance. The “lopping off” of the top of the enforcement pyramid leads the regulator, and subsequent regulatory action, to appear less formidable to businesses who choose to be uncooperative. According to Ayres and Braithwaite (1992, p. 39), it is ‘the existence and signalling of the capacity to get as tough as needed [that] can usher in a regulatory climate that is more voluntaristic and non-litigious than is possible when the state rules out adversariness and punishments as an option’. Compliance therefore needs to appear as the more favourable (and rational) option for non-compliant businesses. As it is not feasible to resort to higher-level sanctions for violations of the regulatory regime, the TGA is unable to deliver a truly effective punishment payoff to sway compliance (Ayres & Braithwaite 1992). RECOMMENDATIONS 1. Existing enforcement measures need to be enhanced to create greater incentive for businesses to comply with the regime. a. Financial penalties should be an option made available to the CRP should businesses fail to comply with initial determinations. b. Financial penalties should be increased within the Therapeutic Goods Act 1989 to make legislated enforcement action more feasible.

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In order for enforcement to be successful, there needs to be an increase in the difference between the cooperation and punishment payoff. Legislative action may rarely be required from the regulator; the formidable nature of the punishment should make cooperation with the regime appear the more attractive option. 2. For such responses to be truly effective (i.e. to deter non-compliant behaviour), regulatory action must be enforceable and form part of a larger graduated enforcement. This is because ‘regulators will be able to speak softly when they carry big sticks… the bigger and the more various are the sticks, the greater the success regulators will achieve by speaking softly’ (Ayres & Braithwaite 1992, p. 19). 3. Mechanisms, such as mandatory adherence to a single, principles based code of conduct, should be implemented to minimise the prospect of law evasion. In addition to enhancing existing measures, additional measures should also be implemented to minimise the prospect of law evasion. For example, adherence to an industry association code of conduct—which I will later argue, should be based on a common set of uniform principles and minimum standards—should be made mandatory for all sponsors with an ARTG listing. THEME 2: REGULATORY REQUIREMENTS ARE NOT COMMENSURATE WITH RISK Issue 1 – Interface between complementary medicines and pharmaceuticals 1. Is the current regulatory regime for complementary medicines in Australia appropriate and commensurate with the risk posed by these products? If not, why not? A major attitude identified from the data was that because the risks inherent to the product (product risk) were deemed to be low for complementary medicines—and therefore had a lesser likelihood of causing physical harm to the consumer—regulatory requirements for complementary medicines should therefore be in proportion to, and representative of, such product risks. Consequently, as was noted in the Review document, many stakeholders associated with industry are of the belief that complementary medicines are largely over-regulated with respect to their perceived product risk profile, particularly in the area of direct-to-consumer advertising and evidence requirements for efficacy. While pharmaceutical regulation must be commensurate with product risk, it is also important that regulation be proportional to the degree of corporate non-compliance (compliance risk). A regime which is not responsive to corporate non-compliance will be exploited by actors who are economically motivated (Ayres and Braithwaite 1992). The current attitude that “regulation must be commensurate with product risk” is in contention with the TGA’s need to respond to compliance risks as they arise. For instance, it was noted from the data that any increases to regulatory requirements proposed by the TGA to address the high levels of corporate non-compliance in product labelling and advertising across industry sectors has been met with backlash and resistance from industry stakeholders throughout the consultation

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process. As a result, the system continues to be oriented towards regulation based on product risk, which fails to be responsive to compliance risks posed by individual sponsors and industry as a whole. Consequently, products with low product risk profiles and with low levels of regulatory oversight, continue to demonstrate high rates of non-compliance, and therefore have higher compliance risk, than those products with higher product risk profiles and higher degrees of regulatory oversight (see Figure 3). Figure 3: Product risk and the degree of regulatory oversight compared with the level of compliance risk.

RECOMMENDATIONS 4. The regime must be more responsive to forms of risk beyond those risks which are simply inherent to the product. The TGA has indicated that it will be producing risk-profiles of sponsors for the purposes of compliance reviews (TGA 2012c). Risk-profiling and the creation of compliance histories however, should be extended to the post-market arena in areas such as advertising and labelling regulation for listed medicines (as has occurred with GMP auditing, see TGA 2013). This was also a recommendation of the ANAO 2011 Audit Report. Issue 4 – Evidence Requirements 1. Are the current evidence requirements for listed medicines overly onerous? If so in what way? 2. How could the current evidence requirements for listed medicines be altered to reduce the burden on sponsors without reducing consumer confidence that complementary medicines are safe, efficacious and comply with quality standards? As this thesis analyses the post-market regulation of non-prescription and prescription medicines—and given that current debates on the evidence requirements for listed medicines

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centre upon the pre-market evaluation of evidence—I am only able to comment on the impact of current evidence requirements from a post-market enforcement perspective. The current requirements—that evidence must be held by the sponsor and supplied to the TGA upon request, and that evidence of efficacy is only evaluated once a product has achieved its listing—has placed a significant burden on the regulatory system. Many advertising complaints involving low-risk therapeutic goods are a result of a lack of evidence to substantiate claims of efficacy (TGA 2012a). Often it is not until a complaint has reached the complaints body that the evidence to support claims of efficacy is evaluated— as not all low-risk therapeutic goods undergo a pre-market assessment or are captured during a post-market compliance review (TGA 2012a). Consequently, the complaints handling process has become ‘slow’, ‘unresponsive’ and ‘laborious’ because bodies such as the CRP are investing ‘too much time in issues of efficacy’ (Industry Association 2, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods). It is argued by stakeholders that: in an optimally functioning regulatory environment, there quite simply wouldn’t be so many questionable advertisements in the marketplace to prompt complaints.… the primary goal of the regulatory environment should be to prevent wrongful conduct in the first place, with swift remedies to follow where prevention has failed. Prevention of breaches is clearly preferably to action taken after breaches have occurred (Complaints Body, in the 2013 consultation Regulatory Impact Statement: Regulating the Advertising of Therapeutic Goods to the General Public).

Many stakeholders therefore agree that ‘low levels of post-market auditing and lengthy complaint procedures are no substitute for proper, effective regulation at the time of market entry for Listed Medicines’ (Industry Association 3, in the 2012 Evidence Required to Support Indications for Listed Medicines 1). It was also been suggested that an increase in the level of post-market review by the TGA would greatly reduce the need for the delegates responsible for pre-approval (i.e. advertising service managers or ASMs) and the CRP to determine matters of efficacy6. A number of stakeholders also expressed the concern that the responsibility of evaluating product efficacy is increasingly being placed onto individuals and bodies who do not have the expertise to evaluate efficacy. For example, there is an increasing expectation being placed on ASMs to establish and verify efficacy issues as part of the pre-approval process—this is because ASMs routinely call for and evaluate evidence of efficacy that may be used to support claims made in advertisements. Advertising claims approved by ASMs are sometimes overturned by the CRP, meaning that ‘[t]he pre-approval of advertisements does not protect the advertisements from complaints once they are published’ (Sponsor 2, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods). 6

It was stated by one stakeholder that: ‘the efficacy assessment of therapeutic goods is the responsibility of the Regulator. Neither the delegates responsible for pre-approval nor the CRP should be used in place of the Regulator for the assessment of the efficacy of therapeutic goods. An increase in the level of post-marketing review by the TGA would reduce the need for the delegates and the CRP to determine matters of efficacy. This is not to suggest that the CRP should be prevented from reviewing data in order to determine compliance with the TGAC. In fact, such a review is essential for determining compliance with sections 4(1)(b) and 4(2)(c) of the TGAC.… the CRP and the delegates responsible for pre-approval should be able to review data used as the basis for claims, but this is not the same as evaluating the efficacy of a product’ (Industry Association 4, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods).

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Such approaches are also not in the public interest, as the lack of prior evaluation of evidence leads consumers to be exposed to misleading advertising claims7. RECOMMENDATIONS 5. The recommendations of the permitted coded indications project should be implemented to reduce the capacity of sponsors to include inappropriate information on the ARTG. If a free-text field is to be made available to sponsors during the listing process so that sponsors are given the flexibility to tailor their indications according to the evidence they hold, then sponsors should be required to submit evidence of efficacy with their listing applications. Those applications where the free-text field is used to create individualised indications should be the primary target of a TGA targeted post-market review. 6. All sponsors should be made to supply evidence supporting product indications upon listing. As many of the compliance risks and complaints facing low-risk listed medicines are efficacy related, the way in which evidence is currently evaluated by the TGA needs to be reconsidered. It would therefore be preferable to have all sponsors supply evidence upon listing. Sponsors are already required by law to have in their possession evidence to support their therapeutic claims at the time of listing and as such, there would be little burden placed on industry to supply this evidence with their listing applications. At the very least, this could take the form of a simple reference list. There are many benefits to supplying this evidence at the time of listing.  Possession of this evidence at the time of listing would enable the TGA to review applications more rapidly without first needing to ask and wait upon sponsors to supply this evidence in order to initiate the review.  Access to this evidence would provide greater direction for the TGA to determine which applications to target as part of a targeted enforcement approach. For example, reviews could be instigated when:  Fewer sources of evidence are supplied with an application.  The sources supplied with the application are largely outdated.  The sources supplied with the application are not reputable, however, what constitutes as a reputable and as a non-reputable source should be negotiated with stakeholders.  It may also act to deter some sponsors from making illegitimate listings since the TGA would have the capacity to review an application at any given time and without prompt.

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‘An honour system where applicants are required to say they hold evidence but not produce it for examination prior to registration is not in the interests of consumer protection’ (Research Scientist, Public Submissions to the TGA Transparency Review).

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Issue 6 – Pre-publication approval for advertising 1. Should Australia continue to require compulsory pre‐vetting of complementary medicines advertised direct‐to‐consumers or should it move towards a self‐regulatory model or combined statutory and self‐regulatory models such as that operating in the UK? 2. If Australia was to adopt a self‐regulatory model or a model which combined risk based regulation with self‐regulation (such as the UK) what key elements would need to be in place to ensure that public health and safety was protected, while minimising regulatory burden? 3. Should listed complementary medicines be required to include a disclaimer in all advertising materials and on product labels advising consumers that statements/claims have not been independently assessed by the TGA? As has been previously argued in this submission, both the self-regulatory and co-regulatory schemes suffer from a lack of enforceability and deterrent effect. Without addressing these regulatory failures, the self-regulatory and co-regulatory regimes will continue to be exploited and those aspects of the regime which cannot be covered by TGA or statutory regulation alone, will continue to result in regulation deficiency. At this point in time, ASMs for ASMI and the Complementary Healthcare Council (CHC) are delegated to approve advertising in certain media. However; depending on the type of product (OTC or Complementary) elements of the same advertising campaign (print, radio, TV etc) may need to go to both associations for clearance. This creates an environment that is both complex and conducive to inconsistent decision making (Sponsor 2, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods).

The current regime is also inequitable as not all forms of media advertising requires pre-approval. Few reasons have been provided by the TGA as to ‘why broadcast media requires more stringent regulation than other forms of advertising’ (Industry Association 5, in the 2010 consultation Improving Advertising Arrangements for Therapeutic Goods). Many stakeholders concede that standardised pre-approval may be impractical given the current financial and resourcing constraints. Should pre-approval for all advertising be infeasible, consideration should be given to placing a mandatory disclaimer on the packaging of listed therapeutic goods, such as “This medicine (or device) has not been evaluated by Australian health authorities for efficacy”. This is because the AUST L label fails to communicate to consumers that these products have not been tested for efficacy. As such: [c]onsumers have a right to be unequivocally informed that listed therapeutic goods have not been tested or approved by the TGA for efficacy [and] the ‘AUST L’ marking would be more meaningful if ‘No data available regarding efficacy’ were added by way of explanation (Sceptic Organisation, in the 2011 consultation Public Submissions to the TGA Transparency Review).

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Pre-approval of advertisements should be made available to sponsors as a voluntary option in these circumstances. RECOMMENDATIONS 7. Without first addressing existing regulatory failures, such as the lack of enforceability and deterrent effect of the current co-regulatory and self-regulatory regimes, a self-regulatory and/or co-regulatory pre-vetting or pre-approval scheme will continue to be exploited. a. If pre-approval were to be applied, it should be standardised. b. Should standardised pre-approval be infeasible, consideration should be given to placing mandatory disclaimers on product packaging to reflect the true regulatory status of the product, and to the development of a voluntary pre-approval scheme. Issue 1 – Interface between complementary medicines and pharmaceuticals 2. Should complementary medicines in Australia be regulated under a separate legislative framework? If yes, what should be the key features of the framework? Issue 2 – Threshold for therapeutic goods 1. Should low‐risk complementary medicines be regulated as general consumer goods, removing the requirement for listing on the ARTG? If yes, why? If not, why not? Issue 3 – Interface between complementary medicines and foods 1. Should certain dietary supplements, such as water soluble vitamins, be regulated as foods or as general consumer goods rather than as therapeutic goods? If not, why not? 2. What is the rationale for continuing to regulate these products as therapeutic goods? If yes, should such goods be regulated as foods or consumer goods? The TGA is in the best position to evaluate and regulate products which claim to have a therapeutic use and which fall under the jurisdiction of the Therapeutic Goods Act 1989. Product claims or statements that do not convey a therapeutic use are already covered under existing Australian consumer laws, such as the Consumer and Competition Act 2010, which falls within the jurisdiction of the ACCC. As complementary and low-risk listed medicines can carry both types of claims, there is no need to create a separate and/or an additional legislative framework to specifically accommodate complementary medicines. This will only create an unnecessary duplication of the law and legal processes. Low‐risk complementary medicines and dietary supplements should not be regulated as either general consumer goods or as foods if they claim to have therapeutic uses (as per the definition under the Therapeutic Goods Act 1989). Products that wish to carry claims for therapeutic uses should be listed on the ARTG, as currently occurs. Those products which do not make therapeutic claims are not considered therapeutic goods under Therapeutic Goods Act 1989, and are therefore already regulated as either general consumer goods or foods, and fall within the jurisdiction of consumer law and the ACCC.

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As per the previous recommendations of this submission, a greater emphasis should instead be placed on enhancing those aspects of the Therapeutic Goods Act 1989 which currently make legal action an infeasible enforcement option for the TGA. RECOMMENDATIONS 8. The regulation of complementary and low-risk listed medicines should maintained under preexisting legislative frameworks—more of an emphasis should be placed on enhancing those aspects of the Act which currently make legal action against non-compliant businesses infeasible. Issue 5 – Compliance with GMP 1. Should Australia remove the requirement for manufacturers of low risk products or ingredients to comply with medicinal Good Manufacturing Practice (GMP) standards? a. If not, why not? What risks do you believe this would create and what evidence is there for this? If yes: i. What are the risks of removing PIC/S requirements? ii. How could these risks be mitigated? iii. What would a complementary medicine‐specific GMP scheme look like? iv. What is the compliance cost of meeting medicinal GMP standards as opposed to GMP standards applying to other products such as foods? GMP requirements are an important public safeguard as they provide a set of common minimum standards that ensure all medicines meet a satisfactory level of quality, safety and efficacy. While PIC/S may not be directly applicable to complementary medical products, many of the standard principles of manufacturing practice would hold relevance to all medicines manufacturers (regardless of industry sector). Incidences, such as the cases of Pan Pharmaceuticals (R v Shayma Jain [2005] NSWDC), ComaxPharma (R v Comax-Pharma Pty Ltd [2008] NSWDC 200) and Curacel International (Department of Health and Aging 2003), along with findings that suggest there may be moderate rates of noncompliance with quality and safety standards (ANAO 2011), demonstrate the importance of having a minimum set of common manufacturing principles for complementary medicines manufacturers. RECOMMENDATIONS 9. A complementary medicines (or listed medicines) GMP guideline should be developed. I would support the development of a GMP guideline specific to complementary and listed medicines in concept. Further consultation is necessary, with the public as well as with relevant stakeholders, to determine which aspects of the existing guidelines could be transferable to the new guidelines, and which aspects will need to be re-engineered.

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THEME 3: COMPLEX REGULATORY FRAMEWORK Issue 1 – Lack of understanding of requirements for listing 1. Should sponsors of complementary medicines have to undergo compliance training before being able to list a product on the ARTG? If yes: a. What evidence is there that such a scheme would increase compliance? b. What would the impact of this be on sponsors in terms of additional costs and time to market? Would it delay consumer access to new products? 2. If not, what other strategies might be put in place to increase sponsors’ understanding of regulatory requirements and/or increase compliance with regulatory requirements? The compliance issues identified by the Review document include: incomplete or inappropriate information on the ARTG; formulation, manufacturing or quality issues; labelling and advertising issues; and inadequate evidence to substantiate claims. As these compliance issues have different causes, each will be discussed individually and in connection with recommendations which have already been supplied as part of this submission. Incomplete or Inappropriate Information on the ARTG The issues surrounding the quality of information inserted onto the ARTG by sponsors is due to the over-use of ‘free-text’ fields during the application process which permit the deliberate or inadvertent entry of incomplete and inappropriate information onto the ARTG (ANAO 2011). The recommendations put forward as part of the permitted coded indications project should be implemented to reduce the capacity of sponsors to include inappropriate information on the ARTG (see the recommendations for Theme 2, Issue 4 on page 12 for further discussion). Formulation, Manufacturing and Quality Issues Australian GMP requirements, which have adopted the standards established by the Pharmaceutical Inspection Cooperation Scheme (PIC/S), are not directly applicable to complementary medicines, which may be in-part to blame for the high rates of formulation, manufacturing and quality issues currently being experienced during compliance audits. The development and adoption of a complementary medicines-specific GMP guideline may assist in clarifying GMP requirements for listed medicines manufacturers (see the recommendations for Theme 2, Issue 5 on page 15). Compliance issues may also be a result of the prioritisation of regulatory oversight and enforcement towards products carrying higher degrees of product risk rather than, and in conjunction with, those products which are considered to be of higher compliance risk (see Theme 2, Issue 1, page 10). Emphasis should be placed on developing compliance histories and risk profiles for listed medicines manufacturers and sponsors in order to identify consistent rule breaking. The TGA can then target these sponsors and apply its graduated enforcement approach. Labelling and Advertising Issues As previously indicated in this submission, advertising pre-approval and complaints handling is conducted across multiple platforms; pre-approval is conducted via ASMI and the CHC, and

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complaints handling occurs via the CRP and complaints bodies operating under the ASMI and CHC. The current pre-approval process is duplicative and resource draining, and on occasion, ‘the same issues [are] being raised by different bodies… because the advertising was appearing via different media’ (Industry Association 6, in the 2010 consultation Improving Advertising Arrangements of Therapeutic Goods). The range of sanctions made available to each of the complaints bodies differ, creating an environment susceptible to inconsistent decision making and conducive to ‘forum shopping’ (Industry Association 6, in the 2010 consultation Improving Advertising Arrangements of Therapeutic Goods). There is also a great deal of diversity between guidelines across the TGA, CRP and the TGACC which has only added to the complexity of the advertising regime. Advertising which has been pre-approved by an ASM is also, at times, subjected to CRP investigations and determinations post-approval (see the response to Theme 2, Issue 4 for further details). Complaints determinations are also unenforceable for those companies that choose not to comply (see response to Theme 4) and for advertisements in below-the-line media by companies who are not affiliated with an industry association—what some stakeholders have regarded as the proverbial “black hole” of the TGA8. Numerous stakeholders across a number of consultations (for example, the consultations: Public Submissions to the TGA Transparency Review; Improving Advertising Arrangements for Listed Goods; and Regulatory Impact Statement: Regulating the Advertising of Therapeutic Goods to the General Public) have consistently argued for the creation of an overarching principles-based Code applicable to cover the advertising and promotion of all therapeutic goods and for the development of a centralised complaints body. Many of the compliance issues being experienced in the area of product labelling and advertising could be addressed by harmonising advertising and labelling requirements, and through centralising the pre-approval and complaints processes. This would reduce the confusion and complexity of the current arrangements, lessening the likelihood of unintentional violations of the advertising regime as a result of a lack of understanding. Inadequate Evidence to Substantiate Claims As low-risk therapeutic goods do not undergo pre-market assessment and are less than likely to be captured during a post-market compliance review, unresolved issues regarding a product’s efficacy and lack of evidence are displaced onto co-regulatory and self-regulatory bodies during post-listing regulatory processes. Many post-market compliance issues associated with inadequate evidence could be resolved by adopting the recommendations listed under Theme 2, Issue 4. RECOMMENDATIONS 5. The recommendations of the permitted coded indications project should be implemented to reduce the capacity for sponsors to include inappropriate information on the ARTG. 6. All sponsors should be made to supply evidence supporting product indications upon listing. 9. A complementary medicines (or listed medicines) GMP guideline should be developed. 10. An overarching principles-based code and a centralised complaints body to cover all therapeutic goods should be created. 8

The issue is allegedly brought to the attention of the TGA, of which it appears to be dealt with internally, without any further information or progress provided on how the complaint is being dealt with. An interview participant described this as the ‘alternate, ill-defined, internal procedure that no one knows about’ (Interviewee 6).

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Imposing compliance training on sponsors would be unnecessary at this point in time, as many of the compliance issues arising from compliance audits can be explained by the inadequacies of the regulatory regime and regulations themselves (implementation failures). As these failures are inherent to the regulatory regime, it is recommended that resources are instead invested to address the inadequacies of the current regulatory framework (rather than creating new requirements for sponsors). Issue 2 – Poor consumer understanding 1. Is the regulation of complementary medicines transparent enough in terms of informing health consumers about the level of scrutiny that the medicine has undergone? If not, how could it be improved? Please see my previous responses to:  Theme 3, Issue 1 regarding the clarification of the regulatory framework.  Theme 2, Issue 6 regarding my recommendations on clarifying the AUST L label. It must be acknowledged that the TGA has of late, taken significant steps towards increasing its procedural transparency by reporting the outcomes of its enforcement activities; information regarding the TGA’s compliance undertakings, complaints handling, court actions, and product cancellation and suspension activities are now viewable on the TGA website. While this is commendable, it must be noted that in some of these reports the details surrounding the TGA’s enforcement action remains extremely vague. For instance, the amount of detail supplied as part of product cancellation and suspension reports is minimal compared to the amount of information contained in advertising complaints determinations—which includes web links to the CRP webpage and the CRP determination. In order to promote greater understanding of these processes, more information should be provided regarding the specific reasons for the suspension or cancellation rather than simply stating which parts of the Act have been contravened. A similar argument can also be made about the detail provided for TGA court actions; it would be appreciated if the TGA created links to the court judgement or made reference to the case number so that interested members of the public can access these cases and their findings. RECOMMENDATIONS 11. Further information regarding TGA enforcement actions should be publicised on the TGA website, specifically the reasoning behind product cancellations and suspensions.

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SUMMARY Although the TGA has made significant progress towards increasing its procedural transparency, the findings of this PhD research suggest that there are numerous sources of failure inherent within the current regulatory regime which, if left unaddressed, will continue to result in regulation deficiency. There are a number of areas in which the implementation of regulation was found to be inadequate (implementation failure) and where enforcement measures lacked the adequate strength to compel compliance (instrument failure). Aspects of the self-regulatory regime were found to be unenforceable and inadequate for deterring misconduct (self-regulation or private law failures). The TGA has also had a history of failing to provide adequate information to all stakeholders, specifically the general public (information failure). Combined with the lack of and need for procedural transparency, the lack of information access led the TGA to be largely unaccountable to its stakeholders and the general public, which in turn has resulted in stakeholder perceptions of bias and clientism. In response to the review questions, this submission has recommended that: 1. Existing enforcement measures need to be enhanced to create greater incentive for businesses to comply with the regime. a. Financial penalties should be made available to the CRP should businesses fail to comply with initial determinations. b. Financial penalties should be increased within the Therapeutic Goods Act 1989 to make legislated enforcement action more feasible. 2. For enforcement to be successful in deterring regulatory non-compliance, regulatory action must be enforceable and form part of a larger graduated enforcement strategy. 3. Mechanisms, such as mandatory adherence to a single, principles-based code of conduct, should be implemented to minimise the prospect of law evasion. 4. The regime must be more responsive to forms of risk beyond those risks which are simply inherent to the product (compliance risks). 5. The recommendations of the permitted coded indications project should be implemented to reduce the capacity for sponsors to include inappropriate information on the ARTG. 6. All sponsors should be made to supply evidence supporting product indications upon listing. 7. Without first addressing existing regulatory failures, such as the lack of enforceability and deterrent effect of the current co-regulatory and self-regulatory regimes, a self-regulatory and/or co-regulatory pre-vetting or pre-approval scheme will continue to be exploited. a. If pre-approval were to be applied, it should be standardised. b. Should standardised pre-approval be infeasible, consideration should be given to placing mandatory disclaimers on product packaging to reflect the true regulatory status of the product, and to the development of a voluntary pre-approval scheme. 8. The regulation of complementary and low-risk listed medicines should maintained under pre-existing legislative frameworks—more of an emphasis should be placed on enhancing those aspects of the Act which currently make legal action against non-compliant businesses infeasible. 9. A complementary medicines (or listed medicines) GMP guideline should be developed. 10. An overarching principles-based code and a centralised complaints body to cover all therapeutic goods should be created.

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11. Further information regarding TGA enforcement actions should be publicised on the TGA website, specifically the reasoning behind product cancellations and suspensions. The evolution and benchmarking of the above points is recommended for future reviews.

I thank you for the opportunity to provide a submission to the Expert Review of Medicines and Medical Devices Regulation – Complementary Medicines. I am available to provide further clarification on those points raised in my submission if required. Rhiannon Bandiera, BBSc Hons PhD Candidate School of Law, Flinders University Sturt Road, Bedford Park Adelaide, SA 5042, Australia Telephone: (08) 8201 3706 Email: [email protected]

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REFERENCE LIST: ANAO 2011, Therapeutic goods regulation: Complementary medicines, Audit Report No. 3 2011-12, Canberra. Australian Self Medication Industry 2015, ASMI Code of practice, ASMI, Sydney, Available from: . Ayres, I & Braithwaite, J 1992, Responsive regulation: Transcending the deregulation debate, Oxford University Press, Oxford. Department of Health and Aging 2003, Brisbane drug company convicted of counterfeiting, Available from: < www.health.gov.au/internet/main/publishing.nsf/Content/healthmediarel-yr2003-tw-tw03009.htm >. [16 October 2014]. Griffin, OH & Miller, BL 2011, ‘OxyContin and a regulation deficiency of the pharmaceutical industry: Rethinking state-corporate crime’, Critical Criminology, 19, pp. 213-226. Parliament of Australia 2014, Performance of the Australian Securities and Investments Commission, Commonwealth of Australia, Senate, Economics Reference Committee, Canberra. Therapeutic Goods Administration 2012a, Advertising regulatory framework: Options for reform, Commonwealth of Australia, Therapeutic Goods Administration, Canberra. Therapeutic Goods Administration 2012b, Listed complementary medicine compliance reviews, Available from: . [24 March 2015]. Therapeutic Goods Administration 2012c, Using risk profiles in listing compliance reviews, Available from: . [24 March 2015]. Therapeutic Goods Administration 2013, Manufacturer inspections – A risk-based approach to frequency, Available from: . [24 March 2015]. Therapeutic Goods Administration 2014, Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaints No. 2012-08010 and 2012-10-024, Available from: . [15 September 2014]. CONSULTATIONS: Public Submissions to the TGA Transparency Review, 2011 Evidence Required to Support Indications for Listed Medicines 1, 2012 Evidence Required to Support Indications for Listed Medicines 2, 2012 Please do not cite without permission

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Improving Advertising Arrangements for Listed Medicines, 2010 Regulatory Impact Statement: Regulating the Advertising of Therapeutic Goods to the General Public, 2013 CASES: R v Shayma Jain [2005] NSWDC R v Comax-Pharma Pty Ltd [2008] NSWDC 200

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