1. Opening Statements

1.1 The Researched Medicines Industry Association (RMI), on behalf of its member pharmaceutical companies, supports the status quo in terms of the pharmaceutical industry's ability, within a mixed legislative and self-regulatory regime, to advertise prescription medicines direct to the consumer.

1.2 In a document "DTC Advertising Can Enhance Public Health - The Case for Direct-to-Consumer Prescription Medicine Advertising", prepared and published in June 2000, the RMI sets out the case, from a public health benefits perspective, for why such advertising should continue. The document responded to all the criticisms and contrary views that have been, and continue to be, put-up against the advertising of prescription medicines to the public and in support of a ban.

1.3 Accordingly, as its first response to the Ministry of Health's discussion document the RMI offers as its reasons for supporting the status quo (option 1) all the arguments already that it has put forward.

1.4 In addition, since the RMI compiled its document, and since the Ministry of Health has published its discussion document, an independent review of the literature, and of the New Zealand experience with direct-to-consumer advertising, has been conducted by Dr Lynne Eagle from the Department of Commerce, Massey University at Albany in Auckland. Dr Eagle's paper, entitled "Direct to Consumer Promotion of Prescription Drugs: A Review of the Literature and the New Zealand Experience" and published in January 2001 as a Department of Commerce Working Paper Series No 01.01, views such advertising in a positive light. Following this review, Dr Eagle maintains there are beneficial effects on compliance (and long-term on health management costs), on aiding openness in the doctor-patient relationship, and on potential savings in other areas of health management such as hospital care. Furthermore, her research finds no empirical evidence for inappropriate or ineffective use of pharmaceuticals attributable to advertising. She reaches the conclusion, too, that pressure reportedly felt by doctors to prescribe medicines requested as a consequence of awareness through advertising appears to be exaggerated.

1.5 Notwithstanding the need for effective mechanisms to monitor all advertising, and to deal with non-compliant activities, this research indicates that a ban on direct-to-consumer advertising of prescription medicines is unwarranted.

1.6 The advertising of prescription medicines direct to the consumer does not occur in an unregulated vacuum. The status quo option involves a plethora of checks and balances to ensure that;

• the products being advertised are safe and effective - prescription medicines are not granted consent to market unless they are proven, on balance, to be safe and effective for the indications claimed by the company and only those indications can be promoted,
• the information provided is balanced and supported by comprehensive additional material and services - a prescription medicine advertisement, particularly on television, usually is part of a fully-researched campaign often with consumers' involvement during the campaign's development but always with comprehensive back-up material for consumers and prescribers, and with prescribers being 'briefed' prior to a campaign's launch,
• access to advertised products is through appropriately educated and trained health professionals with the competence to prescribe - notwithstanding that consumers must be part of the decision-making process regarding treatment options, prescribers are the final gatekeepers and consumers cannot purchase advertised prescription medicines without reference to such qualified intermediaries,
• advertisements that do not meet legislative and code requirements and about which complaints are upheld are withdrawn and amended so that compliance is achieved.

1.7 Accordingly, the RMI contends that no rationale exists, on harm to public health grounds, for a ban on prescription medicines' advertising to the consumer. Furthermore, as will be reasoned in this response to the ministry's discussion document, no other option than the status quo (option 1) will deliver health benefits associated with, or fulfil pragmatic considerations for regulation of, prescription medicines' advertising to the consumer.

1.8 Other arguments against such advertising - arguments about fiscal pressures on the pharmaceutical schedule, and that it puts pressure on the doctor/patient relationship - are, as far as the RMI is concerned, unproven and overstated conjecture. They are not appropriate reasons to ban such advertising. To adopt option 2 (a complete ban) on these bases is more a case of attacking the messenger rather than addressing the messages - that medicines meet legitimate needs; that the public wants, and needs, to know about the availability of medicines and not just from their doctors; that legitimate need for medicines always will drive-up demand for subsidised access and can be managed by other means, and that any illegitimate demand met through prescribers' compliance must be resolved through better education of prescribers.

1.9 These themes further will be developed in the RMI's submission as each option is analysed and, apart from option 1 (the status quo), rejected as inefficient, paternalistic and thus inappropriate.

1.10 As a final introductory comment, the pharmaceutical industry takes very seriously all its regulatory obligations relating to medicines. It works co-operatively with regulators and various 'watchdog' organisations to ensure compliance with legislation and self-regulatory requirements. The evidence-based nature of the industry requires that all therapeutic claims made must be substantiated. Moreover, the industry already has furnished evidence of the health benefits derived from advertising. It is time now for the critics of prescription medicines' advertising to the consumer either to furnish equivocal evidence of harm to consumers, and to the public writ large, or to cease singling-out such advertising as a practice to be denigrated and banned.

2. Terms of Reference - Use as Evaluation Criteria

2.1 According to the discussion document, the review is of prescription medicines' advertising direct to the consumer. This review is being conducted to ensure such advertising is;

• in the best interests of New Zealand consumers,
• safe
• as practicable and as cost-effective as possible.

2.2 These terms of reference are the most appropriate criteria by which to evaluate the various policy options as identified by the ministry. By comparison, those given at the end of the ministry's document - under the heading "Assessment of options: principles and criteria" - merely are re-statements of the terms of reference criteria. Thus as written they will not be used by the RMI in analysing the options.

3. The Regulatory Environment for Advertising of Non-Prescription Medicines

3.1 In response to question 1 in the ministry's discussion document, it is the RMI's view that the regulatory regime governing the advertising of non-prescription medicines must be the same as for prescription medicines. The issues and principles around advertising are the same for both categories of medicines such that the same mix of legal and self-regulatory measures must apply. In that regard, therefore, and especially in view of the RMI's support only for option 1, there is no need for the Government to review the regulatory environment around direct-to-consumer advertising of non-prescription medicines.

4. New Zealand and International Comparisons Regarding Direct-to-Consumer Advertising of Prescription Medicines

New Zealand

4.1 As the ministry's discussion document acknowledges, always there has existed in this country a permissive environment with respect to medicines' advertising direct to the public - prescription medicine or otherwise. The Medicines Act, as did its predecessor - the Food and Drug Act 1969, condones such advertising providing it is within the bounds set down in the legislation.

4.2 The fact that little consumer-directed prescription medicines' advertising occurred in the decades prior to the 1990s is irrelevant in terms of public policy approaches to the principle of advertising. Obviously it was anticipated given the reference in the Medicines Act to publishing and bringing to the attention of the public "in any manner" material that promotes the sale of a medicine - ie medicines' advertising (section 56), and the reference in section 57(2) to advertisements published on television that must be able to be read by the ordinary viewer, ie the public. The legislation has never made any distinction between prescription and non-prescription medicines for the purposes of advertising - instead, relying on other factors such as scheduling, labelling and intervention by health practitioners to provide for prescription medicines a differing level of importance in terms of access.

4.3 Given that at the time the medicines legislation was implemented prescription medicines' advertising direct to the consumer was not considered harmful to the public and thus against the public interest, and given that little has changed in that regard - certainly there is no empirical evidence indicating the public is being harmed from exposure to such advertising, a ban is unjustified. Conversely, the climate today of greater involvement by consumers in their own health care means that advertising to apprise consumers of what medicines are available is justified more than ever was the case in the past.

International comparisons

4.4 Whether or not other jurisdictions allow, or proscribe against, prescription medicines' advertising to the consumer largely is irrelevant in isolation of all the other medicines' control and subsidisation, and health care, policies, also that operate differently in different jurisdictions. The only relevance would be if research emerged from other jurisdictions demonstrating adverse health outcomes arising from exposure to advertising, and only then if the circumstances had relevance to New Zealand's regulatory and practice environments. To date this is not the case.

4.5 In the absence, therefore, of evidence of harm, the international comparisons outlined in the discussion document only serve to illustrate that countries have learned to 'live' with what they have got, and justify remaining with their own status quo on the basis of lack of evidence - for the USA evidence of harm to support a ban, for Australia, Canada and European Union countries evidence of public benefit to support a more permissive advertising environment.

4.6 The comparisons are of no value in terms of guiding New Zealand in the debate.

5. Growth in Advertising Spending

5.1 There is no dispute that the extent of direct-to-consumer advertising of therapeutic products has increased thus spending by advertisers has increased. Nor is it disputed that more is spent on television advertising than all other medias combined - both for prescription and non-prescription products.

5.2 What the RMI would challenge, however, is that this is inappropriate, inherently bad, or indicative of something more sinister such as the industry targeting the sick, the vulnerable and the uneducated emotively to sell product. What it does indicate is a realisation by companies that the public has an increasing 'appetite' for knowledge about, and information on, health matters and treatment options including medicines. Furthermore, that advertising, particularly on television, is the most cost-effective and accessible medium to reach a wide cross-section of people, particularly those in lower socio-economic groups who are proven less likely to visit doctors.

6. The Case For and Against Prescription Medicines' Advertising to the Consumer

6.1 The main arguments for and against, and the main identified costs and benefits of, such advertising largely are speculative, however, it is the RMI's view that even if costs and benefits are overstated, the public is not harmed such that a ban is an appropriate response.

6.2 The point is that there is no evidence of a link, let alone a direct causal one, between growth in prescription medicines' advertising and harm to the public. Harm, if defined in terms of inappropriate use of advertised medicines, only can come about through poor prescribing decisions given the restricted access to such medicines. That, then, becomes an issue for prescribers in terms of their ethical standards, rather than a reason for banning advertising. Furthermore, any link between advertising - and growth in advertising, and an increase in government spending on pharmaceuticals for those advertised products that are subsidised, is not direct.

6.3 In any case, a link is not, per se, a bad thing. Rather than indicating inappropriate and unnecessary use, it demonstrates that unmet need is being addressed. This is especially the case given the safeguard that exists to ensure access to such advertised products only is through competent practitioners. Unless there is evidence that increased government spending on advertised medicines actually is occurring because of inappropriate prescribing then a ban on advertising is unnecessary.

6.4 Medicines are legal products already that have undergone regulatory hurdles to prove safety and efficacy. New Zealand, as a democracy, has enacted rights-based legislation (the New Zealand Bill of Rights Act 1990), that enshrines New Zealanders' rights to freedom of expression, including freedom to seek, receive and impart information and opinions. While some degree of fetter on these fundamental rights is permitted - and in terms of advertising medicines to the public already they exist in the form of the medicines legislation's requirements for advertising, and in the voluntary codes under which the pharmaceutical industry operates, companies have the right to advertise. In addition, consumers have the right to be informed about the existence, and availability, of medicines.

6.5 Unless there are demonstrable reasons for why the rights to freedom of speech (and thus advertising of medicines) should be restricted through an advertising ban, then such a ban is unjustified in a free and democratic society. From any perspective, the arguments put forward by opponents for a ban on prescription medicines' advertising to the public in no way constitute such demonstrable reasons. Even without the Bill of Rights Act, the arguments, as canvassed in the ministry's document, against advertising are weak for reasons now that will be discussed.

Access to information

6.6 The RMI supports all the reasons stated in the ministry's document for why prescription medicines advertising is a positive act to improve consumers' access to some information. Not only does advertising create awareness that medicines are available to treat and manage certain conditions, but in many cases - in all print media particularly - full medicine information is part of all advertisements for prescription medicines. So, too, are directions from where to obtain additional information. Likewise with television and radio advertising where the nature of these media makes it difficult to provide full information. By directing consumers to easily-accessible sources from where the more comprehensive information is available, advertisers are fulfilling their legal obligations, and their requirements to be socially responsible.

6.7 Notwithstanding that advertising is a tool for promoting the sale of a good or service, that is not its only purpose. Promoting awareness of diseases and ill health, encouraging contacts with doctors and other health professionals, alerting to available treatment and providing further information sources are all positive and legitimate rationale behind advertisements for medicines. As was demonstrated at the "Advertising of Therapeutic Products Forum" at the Beehive on 7 December 2000, during the panel discussion on the value of direct-to-consumer advertising, prescription medicines' advertising is not something companies conduct in isolation of other activities to maintain information flows to doctors, pharmacists and consumers. Advertisements do not appear on television in a one-off, 'here today gone tomorrow', sense. They are part of a comprehensive and orchestrated education campaign involving;

• research to determine health and information needs, and how best to meet them - this is an important means by which companies seek to get the balance between the benefits of an advertised medicine and identified risks,
• notification to stakeholders - such as prescribers, pharmacists, Ministry of Health, PHARMAC, etc, - about the campaign and its elements so there are no surprises and people can access the information they require, and
• establishing the sites from which more full information can be sourced - eg, the 0800 phone numbers, information packs to be mailed, websites, etc.

6.8 Opponents of prescription medicines' advertising from the access to information perspective focus only on television (radio is not a significant medium for such advertising) in their criticisms about the lack of balance, and the superficial level of information provided. The transient nature of this medium never will lend itself to the type of full disclosure that such critics demand (nor would this be meaningful to the consumer). On the basis, however, that television advertisements are only part of comprehensive campaigns, and serve mainly to alert people to the existence of possible treatment options for those who may require it, and to other sources of information, television advertisements should be seen in a slightly different light.

6.9 Not only must there be balance in the positive and negative aspects of the treatment being advertised, but balance also must be obtained between simplicity of message and having too much technical information to clutter an advertisement. The latter already has been ruled by the Advertising Standards Complaints Board (ASCB) not to be socially responsible as required by the Advertising Standards Authority's Code for Therapeutic Advertising. Furthermore, the Ministry of Health Medsafe, in developing its guidelines to assist advertisers interpret the requirements of the Medicines Regulations with regard to statements about medicines' indications, contraindications, precautions and adverse effects, specifies that;

"It is sometimes impractical to convey all the risk information in a television advertisement in a coherent way. In these circumstances it would be considered appropriate to direct the consumer to an easily accessible source of additional information. This does not, however, exempt the advertiser from including in the advertisement information about major risks of which consumers should be made aware. Such statements should be considered part of the advertiser's social responsibility in providing balance to any product benefit claims and to informing any specific consumer group of the appropriateness of the advertised medicine.

It is important and responsible to inform the consumer that:

• there are risks to be considered
• there is further information available
• the use of the medicine should be discussed with an appropriate health professional."

6.10 There is, therefore, awareness by the regulator that television advertisements do pose some difficulties for advertisers in terms of getting right, and in a socially responsible manner, the balance between the positive and negative effects. Equally, there is evidence (as reported in the ministry's discussion document) that compliance with all the requirements is improving, not least because of the various systems that have been introduced to assist advertisers understand their obligations. The newly-introduced Therapeutic Advertising Pre-vetting System (TAPS) is the latest initiative that the RMI is confident will improve industry's conformity with legislative and code requirements. The fact that pre-vetting is compulsory adds further to the expectation that improvements will occur.

6.11 Notwithstanding the challenge for advertisers in achieving balance particularly in television advertisements, a general advertising ban, or a ban only on television advertising, is an unjustifiable response to concerns that remain speculative and are unproven in terms of harm to the consumer. In the final analysis, patients gain access to advertised medicines only through prescribers who have a duty of care to prescribe only when warranted following patients' own involvement in the decision-making process.

6.12 Consumers are likely to take offence at the paternalistic attitude from critics that medicines' advertising causes them to be confused and misinformed from too little knowledge, and that exposure to such advertising will cause anxiety for those people for whom the medicine may benefit. In all other aspects of health policy, and health care provision and treatment, the model has moved away from paternalism with its 'doctor/the state knows best' principle, to the 'patient empowerment' model. The situation is no different for consumers being informed about medicines' availability (through advertising as well as other sources such as doctors), and independently gaining access to information about such advertised medicines.

6.13 Finally in terms of advertising and access to information about medicines, there is the issue of the internet - a proliferating source of medicines', and health-related, information and advertising. While measures are being, and will continue to be, taken to ensure material on the internet complies with appropriate standards in this regard, a ban will not prevent the material from appearing and New Zealanders will continue to be 'exposed'.

6.14 Furthermore, medical journals more and more are being published on the web with all their technical and prescriber-specific advertisements able to be viewed by the lay public. The public also can gain access to medicines' compendia that contain prescription medicines' advertising.

6.15 The tide cannot, and should not, be stopped and management is the better option. An advertising ban on prescription medicines direct to the consumer is irrational, and counter-productive at a time when consumers are wanting, and when it is acknowledged that health outcomes are improved by, greater involvement in their own health care.

Fiscal pressures

6.16 The researched-based pharmaceutical industry is in the business of innovation and development of new technology as it relates to therapeutic-based treatments. Once it has developed and gained marketing consent for new products, naturally the industry seeks to apprise decision-makers (and that must include consumers) about the existence, and availability, of the new technology.

6.17 Promotion of the products of innovation is an entirely legitimate activity for all industries and the pharmaceutical industry is no different. The fact that new products may be more expensive - initially anyway, until competition brings other 'players' into the market - is no rationale for what amounts to censorship by critics of such advertising in advocating a ban.

6.18 PHARMAC has argued to the ministry that direct-to-consumer advertising of prescription medicines "places a fiscal strain on the pharmaceutical budget" for reasons of demand. On this basis it seeks for the ministry to ban such advertising. No empirical research has, however, been conducted to demonstrate such a direct link between this advertising and an increase in PHARMAC's spending on a particular medicine, or medicines in general. There are many factors that change, or increase, demand for particular products and to seek, on such spurious grounds, to ban what otherwise is a legitimate and legal activity should not be contemplated, let alone implemented.

6.19 Certainly, no such action should be considered on the basis of PHARMAC's exaggerated claims that "major advertising promotions for FlixotideR, ZocorR and LamisilR led to demand growth for these products and additional expenditure of $7.4million from the pharmaceutical budget" (as reported in the Ministry of Health's discussion document). All three companies the products of which have been singled-out by PHARMAC have, and no doubt will produce for the ministry, evidence to refute PHARMAC's claims thus discrediting the standing of its fiscal pressure arguments against prescription medicines' advertising to the consumer.

6.20 While advertising will have some impact on demand for a product, the relationship is not a direct one and advertising is not the sole reason why demand for a particular medicine increases. Even if demand increases, given that access to prescription medicines only is through prescribers, an increase in demand does not necessarily translate into supply. If it did, and supply was proven inappropriate, there would be questions raised about the competence of professionals to have prescribing rights.

6.21 Nor is an increase in pharmaceutical subsidy expenditure for specific medicines solely the result of their advertising. In the case of the three medicines mentioned above, other factors were involved - factors to which PHARMAC itself contributed. With the ZocorR advertising campaign, an increase in subsidy spending resulted from a change from partial, to full, subsidisation. It was the result also of 'plugging' the PHARMAC-identified treatment gap of patients eligible for ZocorR and its competitor but not receiving treatment - a gap that ZocorR advertising responsibly would have helped close.

6.22 Similarly with LamisilR. PHARMAC's claims in the Sunday Star Times (19 November 2000) that Novartis' LamisilR prescription medicine television advertisement showed "the detrimental effect [direct-to-consumer] advertising has on the pharmaceutical budget" (because of an alleged $540,000 spent on advertising LamisilR the volumes of which consequently "leapt 39% at a cost of $770,000" to the taxpayer), have been exposed by the company as incorrect and misleading.

6.23 LamisilR cream - which is a non-prescription medicine - never has been subsidised by PHARMAC so television advertising campaigns to the public have had no, and cannot, impact on PHARMAC's budget.

6.24 LamisilR tablets - which are prescription medicines and are subsidised by PHARMAC - never have been advertised on television and so this medium has not made a contribution to consumer demand for the product. In addition, the amount spent on this product's advertising in the print media is only a fraction (a little over 10%) of that claimed by PHARMAC.

6.25 Rather than any advertising activities undertaken by the company being the cause of subsidy increases for LamisilR tablets, Novartis points as the main contributor in this regard to the change in dispensing practices - with a move from hospital-only, to community pharmacy, availability. This change, brought about by the Health Funding Authority and PHARMAC, freed-up access to the medicine and thus increased its prescribing when previously its availability severely had been restricted.

6.26 GlaxoSmithKline has evidence indicating that it is not advertising that increases the demand for, and thus the use of, FlixotideR, rather the improved benefit that patients experience on this medicine - benefits understandably that others seek to experience. Over the same time period, and with advertising occurring in New Zealand direct to the consumer, dispensing growth for FlixotideR in Australia and New Zealand was very similar (34% for the former, 32% for the latter), despite no advertising in Australia (as reported in Pharmacy Today, January 2001, page 3). This counters any rhetoric that volume growth with FlixotideR inappropriately is the result of advertising. Instead, it indicates that need, and benefit, are the reasons why medicines are prescribed and used.

6.27 Rather than advertising per se being the sole cause of increased demand, increased supply, and increased expenditure by PHARMAC for subsidised medicines - the "fiscal pressure" argument to which PHARMAC clings in its opposition to advertising, the examples above illustrate that other reasons contribute more significantly in this regard. Furthermore, they illustrate some of the control PHARMAC has over the pharmaceutical budget, and how much discretion it can apply in the exercise of that control.

6.28 In addition, through supply-side mechanisms such as sole supply arrangements; tender programmes; the application of therapeutic group, and reference, pricing; price-volume trade-offs and risk sharing, and through demand-side activities that work on changing doctors' prescribing practices and reducing consumers' expectations for subsidised medicines, PHARMAC has comprehensive control over pharmaceutical expenditure. By declining to list on the pharmaceutical schedule, and thus subsidise, innovative new medicines, or delaying listing by a few years following ministerial consent to distribute, or by agreeing to list only if companies offer 'deals' that provide price reductions for other medicines, PHARMAC further can manipulate its exposure to fiscal risk.

6.29 These control mechanisms are far more direct, and effective, at "distorting demand" than advertising ever can be.

6.30 PHARMAC claims that the "fiscal strain on the New Zealand pharmaceutical budget" is the result of advertising, asserting that advertising is bad and must, therefore, be banned. No cognisance is given to the needs of patients who benefit from treatment with the medicines advertised. When PHARMAC decides to subsidise a medicine, presumably it is on the basis that there is benefit to individual patients - and to society as a whole in terms of improving health and preventing, or delaying, more costly higher-level care, that outweighs the cost to government from subsidising. Presumably also, PHARMAC would expect that if need for subsidised medicines is identified by prescribers then it would be met, irrespective of the outcome to the pharmaceutical budget.

6.31 On this basis, advertising can be viewed in a positive light when it brings to the attention of consumers health issues for which treatment with medicines is possible and for which pro-actively they seek health professionals' assistance. Where that results in medicines being prescribed and subsidised, on the grounds that prescribers act professionally and prescribe appropriately, it indicates legitimate need that advertising has assisted in meeting. For any other 'slant' to be put on the increased use of subsidised medicines suggests something more sinister about management of the pharmaceutical schedule - that consumers are to be kept in the dark about what medicines are available and subsidised, unless they visit a doctor or other health professional.

6.32 Similarly in regard to medicines currently that are not subsidised but that are advertised direct to the consumer. The view - not backed by evidence - that such advertising undermines public confidence in the state-funded health care system because consumers have to pay the full price, and that as a consequence of demand for such medicines PHARMAC then is pressured to subsidise, again suggests a preference for keeping consumers in the dark about new medicine developments. Such censorship never can be condoned in New Zealand society and the RMI would not expect the Ministry of Health on such a basis to make policy regarding advertising of medicines. In any case, again there is no evidence that on the basis purely of advertising driving-up demand, PHARMAC has been pressured into subsidising a medicine previously that was not.

6.33 As a final word about "fiscal pressure" to which PHARMAC maintains it is exposed, the reality is that pressure of all kinds is to be expected for a government agency that has to manage conflicting demands within a limited budget. Furthermore, it is entirely appropriate, and legitimate, that PHARMAC is subject to such pressures in order to maintain transparency, and equity, in its decision-making regarding what products it will subsidise, at what price and through what 'deals' with pharmaceutical companies. In this way, taxpayers can be assured of PHARMAC's accountability for its subsidy decisions.

6.34 To seek to ban prescription medicines' advertising to the public on the grounds that PHARMAC might be pressured to subsidise suggests such pressure works, and that in wanting to be protected in that regard, and left alone to make its decisions in isolation, PHARMAC cannot defend its decision-making criteria. In the final analysis, if prescribers increase the prescribing of subsidised medicines also that are advertised, and if that prescribing is rational, legitimate and appropriate, then volume increases that increase pharmaceutical schedule expenditure is necessary, and something to which patients are entitled.

6.35 Under these circumstances, PHARMAC should be advocating to the Minister of Health the need for an increase in the budget for pharmaceuticals. Attempting to deny the public access to information about the existence of medicines is more an obstruction than a legitimate policy response.

6.36 PHARMAC's activities in managing the pharmaceuticals' budget largely have focussed on prices, subsidy levels and volume control measures. While these activities continue, more and more PHARMAC is looking to demand-side strategies to achieve the control - strategies to achieve the rational use of medicines. Unlike critics of direct-to-consumer advertising of prescription medicines who maintain that pharmaceutical promotion undermines rational prescribing programmes, the RMI views such advertising as an important contributor to the rational use of medicines. It is a way for high quality information regarding industry innovation to be diffused to the public and to health professionals.

6.37 The same conclusion has been reached by the Working Group on Pharmaceuticals and Public Health - a group established by the High Level Committee on Health (HLCH) (that provides the European Commission with advice on matters relating to health policy), and asked by it to "explore issues related to the costs, use and cost-effectiveness of pharmaceuticals and on pharmaceutical programmes and policy measures". In its report "Pharmaceuticals and Public Health in the EU: Proposals to the High Level Committee on Health for Policies and Actions in the Framework of the Treaty of Amsterdam", published 28 March 2000, the working group concluded that to "promote the rational use of medicines it is necessary to have promotion of medicines by pharmaceutical companies based on accurate information" - ie, "information accurately that reflects officially-approved documents" such as data sheets and consumer medicine information. Advertising to the consumer is in accord with such principles. Doctor-patient relationship

6.38 The nature of the doctor/patient relationship has been under scrutiny, and undergoing change, for the last decade or so. The agency nature of that relationship - where the doctor, as the more informed agent, acts on the patient's behalf in a paternalistic way - no longer is appropriate. Medical professional dominance is giving way to the model of partnership - of patient empowerment - where patients have access to information and are involved in decision-making processes about options for their own health care. This greater involvement in self care only can improve health outcomes. To the extent that advertising increases consumers' awareness about the availability of specific medicines to treat specific illness, and encourages them to seek advice and assistance from health professionals, it is a positive and necessary activity.

6.39 Elements of the medical profession may have difficulty accepting the different dynamic in their relationships with patients - the fact that patients now are prepared to question, to investigate matters for themselves, to source information and to seek to discuss, and even request, treatment options including medicines that are being advertised. They may find it hard to manage seekers of specific medicines who threaten to find more compliant persons when medicines they request are not prescribed. These are not, however, legitimate reasons for banning medicines' advertising and cutting-off for consumers a source of awareness about medicines' availability.

6.40 Instead, they are reasons for providing to the medical profession, and other prescribing health professions including pharmacists in relation to "restricted medicines", assistance in managing their patient relationships, and the pressures that arise from the many different sources - not just medicines' advertising. As with PHARMAC, medical practitioners have no moral justification for being protected from pressure. It 'comes with the territory' and is in the nature of the position of power that they hold.

6.41 Even if doctors consider they are being pressured to prescribe the latest advertised medicine, capitulating without legitimate clinical reason is not a sound reason for effecting an advertising ban. Instead, techniques need to be learned, and applied, for avoiding the outcome of such pressure. As is the case with controlled drugs for abuse purposes, and with pressure to prescribe laboratory tests, the medical profession is better off learning how best to manage the more demanding patient seeking specific services without legitimate need/benefit.

6.42 Unless there is evidence of harm to the consumer from advertising resulting in pressure on doctors to prescribe inappropriately and thus affecting adversely the clinical outcome for patients, a ban is a 'sledge hammer to crack a nut' approach. Furthermore, any suggestion by the medical profession that time is wasted when spent explaining to patients why a requested medicine as seen in an advertisement is not appropriate is likely to be view by consumers as arrogant and paternalistic. While it might justify a higher fee for a longer consultation required also to discuss more appropriate treatment options, it is no justification for an advertising ban. In fact, it is more likely the case that doctors spend a great proportion of their consultation time seeking to explain to patients the latest PHARMAC policy yet again that requires them to be 'switched' to another, different, brand of medicine, or why their next supply will cost them money when before it did not. Medicalisation of the population

6.43 Without evidential studies proving that advertising medicines (all types, not just prescription) direct to the consumer leads to an "increasing tendency for people to seek pharmacological treatment for a growing number of conditions" (medicalisation), or that as a consequence this is something to be avoided, then any support for an advertising ban on such grounds is irrational.

6.44 Furthermore, seeking to apply the precautionary principle against allowing direct-to-consumer advertising is counter-productive. Even if patients request, and are prescribed, medicines that are being advertised, the lack of evidence of harm is the salient point. With the proven ability of advertising to encourage people to consult their doctors/pharmacists about previously undiagnosed medical conditions, and with increasing evidence demonstrating that improvements in public health are achieved through increased use of pharmaceuticals (see the RMI's earlier publication "DTC Advertising Can Improve Public Health"), the need for a ban is not established.

6.45 When a product is granted consent to distribute, it has demonstrated to experts that it is effective for the claims being made, ie for preventing or treating illness or for alleviating symptoms. While need for a medicine per se is not a criterion for consent, there is an element of comparison against what already is on the market to perform the necessary function. Consent is granted when the new medicine is as safe and effective, or better, than current therapies. To the extent that the availability of medicines generally through this process is "medicalisation" then that is to be encouraged, especially when it delivers solutions for serious and debilitating, or discomforting, health conditions.

6.46 The RMI contends that rather than direct-to-consumer advertising being the cause of "medicalisation", it is the response to the medicalisation already that has been acknowledged and developed - through existence of an illness or disease for which medication is sought. For all the reasons advanced already by the RMI, both in this submission and in the "DTC Advertising Can Improve Public Health" publication, there are public and private health and welfare benefits from medicines' advertising.

7. Support for Advertising of Prescription Medicines Direct to the Public

7.1 In response to question 3 posed in the ministry's discussion document, the RMI finds no compelling arguments against prescription medicines' advertising direct to the consumer such that a ban is required. Opponents' views are speculative about the negative role such advertising has on information access, fiscal pressure on the budget for pharmaceuticals, on the detrimental effects for the doctor-patient relationship and on the propensity to seek pharmacological interventions.

7.2 The ministry's own discussion paper, and the RMI's earlier document "DTC Advertising Can Improve Public Health", both cite references for studies that demonstrate the positive aspects of such advertising. In addition, this submission from the RMI has provided rebuttal to the arguments being advanced for why such advertising should be banned.

7.3 The conclusion reached is that advertising is beneficial and must be allowed to continue.

8. Policy Options for Regulating Prescription Medicines' Advertising to the Consumer

8.1 The following terms of reference established for the review of direct-to-consumer advertising now will be used as criteria to analyse the various policy options that have been proposed for regulating prescription medicine advertising' to the consumer; · whether or not such advertising is in the best interests of New Zealand consumers, · whether or not it is safe, and · whether or not it is practicable and cost-effective to regulate and monitor. Option 2 - a ban on such advertising

8.2 The RMI rejects this option.

8.3 Not only is it contrary to the rights of consumers to receive from advertising the information that specific medicines are available to treat specific conditions, it cuts across the fundamental rights of advertisers to inform consumers in this way. While there is no suggestion from the RMI that these freedom-to-inform rights should be unfettered, a ban is far in excess of what is required to ensure the public is protected from inappropriate and unsafe practices.

8.4 Using the above criteria, · Serving the interests of New Zealand consumers - from the rights-based perspective to be informed about medicines' availability, and from the perspective that such advertising does have proven benefits particularly in terms of reaching at-risk and under-treated groups, a ban does not meet this criterion. · Safety - there is no evidence that advertising results in inappropriate prescribing such that consumer safety is compromised. · Practicable/cost-effective regulatory control - forcing consumers to have to consult with doctors in order to learn about the availability of specific prescription medicines not only is patronising, it is completely impractical, especially for sectors of society that can afford such visits the least - further disadvantaging them, and for those in isolated communities. Policing a ban, particularly with internet and international television/satellite coverage in this country, would be ineffectual without huge resources never that are going to be available. on all three counts, the ban option is counter-productive, unnecessary and of no merit.

8.5 At the end of the day, in the absence of demonstrated harm from such advertising, consumers can be trusted to know what is in their own best interests, to receive advice and information from a range of sources, and to act accordingly.

8.6 Previously, the medical profession as represented by the New Zealand Medical Association, and the Consumers' Institute, both were calling for a ban on prescription medicines' advertising to the consumer. Now, the organisations' spokespeople both have backed away from this position. As reported in New Zealand GP (12 December 2002, page 1), Dr Pippa MacKay stated at an end-of-year forum on the subject that "the medical profession does not support an outright ban" since a ban would be seen by patients as being "paternalistic and professionally protective". She acknowledged, however, that "we (the medical profession) have concerns" such that "we support tighter restrictions and more detail about the downsides".

8.7 Similarly David Russell from Consumers' Institute with his comments made at the forum - "I'm not advocating a ban" (with the proviso "as yet") thus giving the 'green light' for the industry to prove itself responsible in its advertising activities.

8.8 In rejecting option 2, therefore, the debate hangs on the degree of fetter that is necessary to maximise the interests of consumers, and ensure safety, in the most practicable way for least cost. Option 1 - the status quo option

8.9 The RMI supports the status quo option - the existing regulatory regime that comprises legal, and self-regulatory code, requirements, along with various guidance mechanisms to aid with interpretation of, and compliance with, the requirements. As is demonstrated throughout this submission, option 1 meets all three evaluation criteria by delivering public health benefits, by being safe and socially responsible and by providing a flexible, industry-responsive and cost-effective administrative system for evaluating advertising compliance with the necessary requirements.

8.10 It is important also to acknowledge that this status quo option actually provides a strengthened, more stringent, regime than was the case at the time - between November 1999 and February 2000 - when the Ministry of Health Medsafe conducted its review of prescription and non-prescription medicines' compliance with advertising requirements. From 1 November 2000, the TAPS compulsory pre-vetting service for therapeutic advertising replaced the previously-administered advisory service. Now, all new therapeutic advertisements and advertising campaigns to be published in all media the organisations of which are members of the Advertising Standards Authority (ASA) have to be 'cleared' through this pre-vetting system still that has a considerable advisory component to it. The aim is to ensure compliance with all legislative and code requirements, and particularly to assist with achieving the balance between the benefits and pitfalls of individual therapies - the area about which there is the most comment, and apparent, controversy. Over time but within the year, existing campaigns also will be vetted for compliance and amendments required if necessary.

8.11 The move from a voluntary pre-publication advisory service, to a compulsory pre-vetting one, provides an element of the more stringent option for which the NZMA and Consumers' Institute representatives are calling as an alternative to a ban.

8.12 RMI member companies have supported introduction of TAPS despite its added cost and inconvenience. To the extent that it provides a degree of 'comfort' in balancing all the elements with which compliance is required, then companies will work within the more stringent rules. The RMI and its member companies consider that the new TAPS system must be allowed to 'bed down', and prove its benefits, before any further change to the regulatory environment for prescription medicines' advertising is sought by opponents.

8.13 The new TAPS requirement, along with the other existing components of the regulatory system - the Medicines Act and Regulations, other general consumer protection legislation, Medsafe's advertising guidelines, the ASA Code for Therapeutic Advertising along with various other relevant codes it administers, and the RMI and NMA codes of practice, provide the right degree of fetter against the fundamental right of companies to advertise, and consumers to be informed. In no way are these requirements light-measured and straight forward with which to comply. They are onerous and have involved considerable effort by companies to educate personnel in understanding, and meeting, the requirements. Yet, RMI member companies have acted responsibly in supporting all the various components of the regulatory regime. Furthermore, as an industry association the RMI has worked responsibly with the various compliance-monitoring agencies - Medsafe, ASA, Consumers' Institute - and brought to members' attention all relevant material to assist with understanding, and complying with, the requirements.

8.14 Contrary to opponents' views, the current system of self-monitoring and control is very successful, both from an education perspective and in terms of effecting action for non-compliant adverts. In addition, once TAPS gains 'traction', the RMI has confidence that the level of compliance will improve as demonstrated by a decrease in the number of complaints made and upheld, and a reduction in the calls for a ban to be implemented on such advertising.

8.15 No doubt when responding to the ministry's discussion document the ASA will provide detail on how compliance with the self-regulatory system is monitored and enforced, demonstrating its effectiveness. In brief, however, following investigation, where a complaint to the ASCB is upheld and there is a breach of legislative or code requirements, the advertisement has to be withdrawn, and amended before it can be re-published. Cynics might say "the damage already has been done" in the sense that the advertisement already has had an impact before being withdrawn. In response, however, the complaints' assessment and response procedure is swift and action taken quickly against non-compliant advertisements. The RMI expects this issue will be less of a concern once the effect of TAPS is 'felt'.

8.16 From the perspective of companies the advertisements of which are the subject of complaints - especially those upheld, non-compliance is a huge and costly issue, both financially and reputation-wise. Decisions by the ASCB against advertisements are not liked by companies undertaking the advertising, however, as far as RMI member companies are concerned they have accepted such decisions and complied fully with recommendations.

8.17 This is self-regulation working well in practice. Furthermore, it demonstrates the system's flexibility. While the Ministry of Health Medsafe has the ability to prosecute advertising that is non-compliant with the medicines legislation - and it does in certain circumstances, the time-frame from complaint and investigation to prosecution can be a long one. Furthermore, prosecution is resource-intensive whereas the industry self-regulatory system involves far less cost, is industry funded and has the more immediate desired result.

8.18 Another comparative advantage is the flexibility of the system to respond to issues that are impacting in the advertising arena. By way of example, the ASA Code for Therapeutic Advertising originally was promulgated in 1996, but in the knowledge that therapeutic advertising, particularly for prescription medicines, still was in its infancy and that the code would require revisiting. Two years later, as planned and in the light of experience, revision occurred. The review process involved consultation with, and input from, all the key stakeholders such as Ministry of Health Medsafe, PHARMAC, NZMA, Consumers' Institute, etc. The current, more stringent and clear, code was published in early 1999. At that time also, Medsafe commenced developing its guidelines to assist with interpretation of the medicines legislation requirements - again in response to demonstrated need for such guidance.

8.19 Initially, there was no advisory service around therapeutic advertising and that gap was 'plugged' when ANZA established the Therapeutic Advertising Advisory Service (TAAS). Now, further in the light of experience, the more stringent TAPS pre-vetting system operates.

8.20 It is not, therefore, correct to say that the self-regulatory mechanism is not successful. It is responsive and flexible, cost-effective through user-pays, and has buy-in by all the 'players' in the system.

8.21 Applying the criteria against which to measure option 1,

• Serving the interests of New Zealand consumers - material provided throughout this submission supports the perspective that advertising of prescription medicines direct to the consumer has important benefits that serve consumers' interests. In addition, the self-regulatory nature of the monitoring and compliance regime, backed by legislative principles and enforcement in cases of serious breach, is working to ensure standards of advertising are maintained and improved. Introduction of the new compulsory pre-vetting system further will enhance compliance to ensure advertising meets socially responsible criteria such that there is greater balance in the benefit-risk information conveyed in advertisements.
• Safety - with the lack of any significant safety/harm issues around the fact that consumers are 'exposed' to prescription medicines' advertising, and in view of the increasingly successful outcomes, and on-going improvements in standards of advertising, achieved through the self-regulatory regime, the status quo option is the only one to pursue. Its flexibility to re-interpret socially responsible requirements, where safety for the public is an issue, further adds weight to the choice of option 1 as the most rational.
• Practicable/cost-effective regulatory control - the self-regulatory model's flexibility to respond to changing interpretations is its greatest strength. To have to prosecute every time the legislation is breached, or to amend legislation every time a new issue arises, would involve huge cost with which government could not comply easily. The fact that the self-regulatory system works has been demonstrated by changes made to the ASA Code for Therapeutic Advertising, along with complaints that have been upheld and advertisements that have been withdrawn or amended. High-level compliance by industry with the self-regulatory system, and industry meeting compliance and enforcement costs, ensures cost-effective outcomes that could not be achieved easily with any other regulatory arrangement.
• all are met such that this option is the best.

8.22 There remain issues around the need for the Medicines Regulations, particularly regulation 8, to be reviewed to reflect the focus in advertisements that should be placed on social responsibility and advertising that is meaningful to the consumer. The RMI does not, however, consider such a review in any way constitutes support for option 3 in terms of more stringent rules and regulations.

Option 3 - industry self-management (status quo) but under more stringent rules and regulations

8.23 This option is rejected by the RMI. While it maintains industry self-regulation, the necessity for tightening the regulatory regime with more stringent rules and regulations does not exist.

8.24 As has been argued already, the current system does work, and will work better as the TAPS pre-vetting system has its influence. TAPS is a more stringent requirement and in this regard it meets option 3's tightened regulatory regime specifications. The fact that TAPS already has been introduced further is evidence of the satisfactory nature of the status quo - option 1. There is every expectation that greater balance in the benefit-risk message conveyed in advertisements, particularly those on television, will be achieved through the influence of TAPS such that advertising generally will have greater meaning for the consumer.

8.25 As mentioned above, there is a need to review aspects of the Medicines Regulations (regulation 8), however the need does not arise because of a desire to see greater stringency, rather to ensure advertisements focus on their social responsibilities, and are more meaningful to the consumer. Furthermore, the need for review does not constitute support for option 3.

8.26 None of the more stringent conditions identified by the ministry for option 3 in any way are considered by the RMI to be acceptable fetters on the ability generally for companies to advertise prescription medicines to the public. The fiscal pressures that are claimed to arise from such advertising are unproven in any direct way, and overstated by PHARMAC - as has been demonstrated from companies' responses to PHARMAC's claims made in this regard (see paragraphs 6.19 to 6.26 of this submission). To seek, therefore, by law to restrict advertising such that certain medicines - subsidised medicines - cannot be advertised, thus protecting PHARMAC from the potential that it might be pressured to subsidise to higher levels, is unjustified. Moreover, there are practical difficulties in taking such a stand given that for many medicines, subsidy occurs only for very restricted indication ranges beyond which the products could be advertised. Control in this situation would not be practicable, efficient or cost-effective. Also, the subsidy 'status' for medicines changes constantly increasing compliance costs further.

8.27 In addition, and from a rights-based perspective, restrictions posed by this option are unacceptable, unnecessary and out of proportion to the perceived-but-unproven 'problem'. They demonstrate clearly that PHARMAC is concerned about its ability to withstand pressures and influences that sector groups legitimately bring to bear to influence the debate about what should be subsidised. PHARMAC, in calling for a ban on advertising subsidised medicines, is looking to remove the influences so that it cannot be swayed. Further, it suggests that unmet need identified through advertising should remain unmet rather than for it to increase pharmaceutical schedule spending.

8.28 It is the RMI's view that PHARMAC, in making medicines' rationing decisions that result in people being denied access to specific medicines, has a duty, and a moral obligation, to make its decisions in the face of all the competing interests and influences that are applied by all the groups with a 'stake' - clinicians, patient groups, patients, medicines' manufacturers, pharmacists, etc. It must be cognisant of the influences and pressures and not seek to be removed from them as even a partial ban, on advertising subsidised medicines, is endeavouring to achieve.

8.29 In the final analysis, PHARMAC has a vast array of mechanisms with which to control pharmaceutical schedule expenditure already as has been outlined in this submission (see paragraph 6.28). To have more control is inappropriate and unnecessary. It would result in the balance of power being shifted too far towards government and the bureaucracy. Furthermore, through its contracts with individual companies PHARMAC has considerable flexibility to control for the supply and price/subsidy of individual medicines such that a partial, or complete, ban on advertising prescription medicines is an unnecessary insurance policy and one the public of New Zealand cannot afford.

8.30 The existing regulatory arrangements, that all are part of the status quo option 1, provide the ability to deliver on most of the other more stringent conditions listed by the ministry under option 3. The ultimate, and strongest, penalty for non-compliance is to have the advertising withdrawn, or to have to alter it - both of which occur at present. Fines also can be applied and prison terms possible, so where is the necessity to increase these sanctions and penalties? In addition, both the advertising media in which non-compliant advertising is published and the company the product of which is advertised already are subject to penalties.

8.31 As to prohibiting a company from any further advertising following a breach of the regulations (already when it has been sanctioned for the breach), such double-jeopardy could not be condoned.

8.32 The RMI's response to the final of the "more stringent conditions" - advertising only when "real benefit" has been demonstrated - also is negative. Not only does this add another layer of bureaucracy further that fetters companies' rights to advertise legal products that have been granted consent to market on grounds of safety and benefit, but it is patronising to the public that can decide for itself what is in its best interests.

8.33 Again, coming back to the terms of reference criteria for assessing the options,

• Serving the interests of New Zealand consumers - with the status quo option (option 1) now including the more stringent compulsory pre-vetting system, there is a need to let this 'bed-down' and demonstrate greater balance in benefit-risk information to the consumer. Rather than advancing consumers' interests beyond the level achieved with option 1, a more stringent option that prevents consumers from being advised about subsidised medicines unless they visit a doctor or unless a government department has deemed a campaign to be in their interests, only can diminish those interests.
• Safety - as safety is not an issue, more stringent rules and regulations cannot be justified. In fact, with more stringency limiting consumers' awareness of medicines, safety actually is compromised especially for untreated conditions otherwise that for advertising would not be brought to attention.
• Practicable/cost-effective regulatory control - in not meeting the two criteria above, as a consequence option 3 also fails this criterion. Consumers' interests are not advanced beyond the level obtained from option 1, and safety is not in question, which means a more stringent option just adds more cost for monitoring and compliance with no improved outcomes. Costs associated with reviewing the Medicines Act - or whatever legislative tool is used to impose the more stringent requirements - are unjustified and industry buy-in would not occur such that compliance costs would increase.

option 3 fails on all three grounds.

Option 4 - government agency management of advertising under more stringent rules and regulations

8.34 For all the reasons given in discussion about option 3, the "more stringent rules and regulations" component of option 4 is rejected by the RMI.

8.35 Most of the costs identified by the ministry as associated with the option 4 model are endorsed by the RMI as a reality - with the exception of the fiscal-pressure-on-the-pharmaceutical-budget cost for reasons already that have been canvassed.

8.36 Also, for reasons that have been given, the RMI gives no weight to any of the arguments in support of the benefits arising from a more restrictive regime that is managed and monitored by a government agency. There is no evidence of any of the risks occurring (eg the vulnerable being exploited, etc) such that greater restrictions, and greater government intervention, in the advertising of prescription medicines are warranted. Certainly, the large increase in cost to government for managing the entire advertising regulatory regime, especially at a time when industry management and user-pays in other sectors of activity is the rule, cannot be justified. With no legitimate benefits to be gained, the RMI questions the logic for this option?

8.37 There is no denying the need for government by way of legislation to set principles by which advertising should be conducted. However, for all but the most serious breaches for which consumer safety clearly is at risk (for example the advertising of a product for which consent to market has not been given, or false advertising of therapeutic) claims, self-regulatory mechanisms for managing compliance are more flexible and efficient, and less costly, to operate. That this system is acceptable for the aviation industry suggests its relevance and appropriateness for management of the regulatory environment for medicines' advertising, especially when safety to the public is not a proven issue.

8.38 Full government control of the advertising regulatory environment and process implies there is greater virtue in government over industry in this regard, that government is guaranteed to do a better job, and that the general taxpaying public should be pleased to pay the bill. The RMI would consider there are far more important and significant activities deserving of government assistance than compliance monitoring of prescription medicines' advertising beyond setting the regulatory framework principles, and prosecuting gross and serious violations of the law.

8.39 Turning finally to the terms of reference criteria for assessing the options,

• Serving the interests of New Zealand consumers - as per option 3, the "more stringent rules and regulations" aspect of option 4 is not going to serve the interests of New Zealanders in any better way than option 1. Government involvement in full operation and management of the regulatory system is no guarantee of improved advertising compliance and to force it through prosecutions will cost tax payers considerably, for little return. Prosecutions would not be taken lightly, nor more quickly (compared with the ASCB system), with the result that responsiveness and accountability are likely to be diminished. Furthermore, a system grounded entirely in legislative control is far less flexible to respond to changed perceptions about social responsibility in advertising.
• Safety - as with option 3, because safety is not an issue more stringent rules and regulations are not justified. For a government agency to take control in overseeing industry compliance the impact on safety would be non-existent. · Practicable/cost-effective regulatory control - option 4 does not meet the two criteria above, therefore, it fails this criterion also. The costs associated with this model are not offset by any improvements in benefits beyond what exists with option 1. The loss of flexibility, plus loss of industry co-operation, means that option 4 is a step backwards.

9. Accountability under Self-Regulation

9.1 As to accusations that the current self-regulatory regime lacks transparency and accountability, and that in being voluntary compliance is flouted, this is not borne-out in fact. Any person, organisation or government department can make a complaint to any of the agencies that administer the various codes affecting medicines' advertising, or to the Ministry of Health in regard to the medicines legislation.

9.2 Those agencies are assiduous about processing and investigating all complaints. All have complaints' assessment boards that have combined lay and expert advisors, often with independent chairpersons. Complaints' activities are experiential such that precedents are set and 'case law' developed for adjudicating on subsequent complaints. Breaches are publicised and compliance with penalties ensured. The ultimate penalty is for an advertisement to be 'pulled' from the media - either permanently or until amended - and the ASCB has proven its willingness to do this. A prosecution under the Medicines Act also can mean imprisonment. Now with TAPS, assessment for compliance with all the requirements is compulsory, however, this does not prevent complaints from being lodged and upheld, and for TAPS-approved adverts still to require amending. Accountability is very much a feature of the self-regulatory system.

9.3 Flexibility, too, is achieved with the self-regulatory system such that the interpretive nature of advertising codes and guidelines easily can be amended - far more easily than an act or regulation - to reflect changing social mores about the tone, and nature, of medicines' advertising.

10. Conclusion

10.1 Option 1 - the status quo that includes the newly-introduced compulsory pre-vetting system - is the only option the RMI supports. While there are always improvements that can be made to advertising practices, and to the rules around interpreting and complying with requirements, the self-regulatory model backed by legislative overview is the most flexible and cost-effective, and promotes consumers' interests through informing about the availability of medicines.

10.2 Balance in information conveyed through advertising is important and industry is working to ensure this is achieved in a manner that is meaningful to the consumer. To this end, industry is confident the compulsory TAPS system will demonstrate ongoing improvements in that regard.