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SELF CARE – EMPOWERING CONSUMERS FOR A HEALTHY AUSTRALIA

THE INTEREST IN SELF CAREAcross the community there is greater awareness of the many things people can do to maintain good health and wellbeing. Self care embodies the notion of people taking greater personal responsibility for their health through nutrition, exercise and appropriate use of self-medication to maintain good health, prevent and treat illness.

WHY SELF CARE IS IMPORTANTGood health is a precious commodity. Many people are aware that keeping well and staying well is a key to a productive and longer life. There has been a range of major Government reports outlining the benefits to individuals, communities and the nation from improved personal health. The increasing cost of national health is also exerting considerable strain on health budgets. It is forcing everyone to examine what can be done to help prevent disease, manage existing conditions and improve the quality of life and general health of the population more cost-effectively.

ASMI ANd SELF CAREASMI believes that self care brings the real prospect of improved health outcomes across the entire community. It is something that needs broad involvement - consumers, healthcare professionals, government and industry - working together. ASMI believes Australians can be handed the knowledge and tools to take responsibility for their health and help build a healthier country through a partnership approach.

Contents Self Care: The foundaTion for a healThy auSTralia ifC

PreSidenT’S MeSSage 2

CoMMiTTee of ManageMenT

exeCuTive SubCoMMiTTee

SubCoMMiTTeeS, PanelS and TeaMS 3

aChieveMenTS TowardS The STraTegiC objeCTiveS of aSMi 4 - 5

rePreSenTing aSMi in inTernaTional foruMS 6

aSMi rePreSenTaTion on Key exTernal CoMMiTTeeS 7 aSMi STePS inTo SoCial Media 8 - 9

exeCuTive direCTor’S MeSSage 10 - 11

aSMi SeCreTariaT 12

aSMi MeMberS 2009 - 2010 13

aSMi annual awardS and ConferenCe 14 - 15

ouTCoMeS of ProMoTional Panel reviewS 16

ouTCoMeS of CoMPlainTS 17 - 20

abouT aSMi: rePreSenTing The auSTralian ConSuMer healThCare induSTry

aSMi viSion, MiSSion and valueS ibC

ASMI’s self care strategic objective continues to be a focal pillar of our activities. As well as maintaining our discussions with government and our collaborative efforts with pharmacy and other key stakeholders, this year we also took our message direct to consumers with the launch of a suite of social media sites. Our Facebook page, Twitter and Blog have gathered growing interest – in the case of Twitter, we’ve collected followers not only from the general public but from stakeholder groups and both sides of government.

In support of greater personal responsibility, we will also maintain our calls for more work to be done on health literacy, to ensure that all Australians have the tools and materials to find, understand and use the information they need to make informed decisions about their health. This is a focus we share with several key stakeholder groups and our initial discussions with them on possible collaborations have been very promising.

ASMI itself has undergone noticeable change in 2010 with the retirement of Executive Director, Juliet Seifert, after an impressive 21 years in the role. Juliet’s influence in the industry cannot be overstated – she has been involved in, and indeed helmed, many of its biggest achievements. I take this opportunity to thank Juliet for her untiring dedication to the Association, its Members and the wider industry. Hers is a legacy that will be long remembered and we wish her the very best for the future.

I welcome new Executive Director, Deon Schoombie, to the role – under his leadership, the ASMI secretariat will continue its work with key health stakeholders and consumers on behalf of our Members. My words of appreciation must also go to the secretariat, which has supported this smooth transition without a lapse in the service we aim to provide to our membership.

President’s Message

In the political context, 2010 will probably go down in the memories of most Australians as one of the more extraordinary years in our nation’s recent history.

We waited, at first with bated breath, then with increasing anxiety, as our country came to be ruled by the first minority federal government in 70 years. We hope that this new arrangement will provide the stability and effectiveness that our country needs. For our industry, a key concern is that the opportunity for health reform initiated by the Rudd Government in 2007 keeps its momentum. Labor’s return to government may promise that many of the earlier initiatives in this area could be picked up where they were left in August, unless however, more pressing issues take precedence on short-term ‘to do’ lists – things such as the mining tax, national broadband network rollout and reshuffled ministers settling into their portfolios.

Rest assured that ASMI will definitely pick up where we left off by re-establishing our contact with ministers, parliamentary secretaries and the departments. ASMI enjoys a respected standing in Canberra as the voice of our industry. That standing is the basis on which we will pursue constructive health reform and ensure it remains at the top of the Government’s ‘to do’ list.

We will also continue to challenge the risk-averse regulatory environment, with an emphasis on achieving better health outcomes through evidence-based decision-making in this area. The recent restructure at the Therapeutic Goods Administration (TGA), while welcome, also threw up some challenges for the non-prescription medicines sector, which call on us to respond and contribute to the discussion by working together with the regulators.

In conclusion, I thank our Members for their ongoing support of the Association, their input, feedback and guidance, and their faith in ASMI to do what needsto be done. We hope you agree that we are stilldoing it well after all these years and, as we moveinto a new era, this is one constant that remainsassured.

Ralf Dahmen, ASMI President

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asMi CoMMittees and teaMs

CoMMittee of ManageMent

exeCutive subCoMMittee

From top left to right: Paul Brown, GlaxoSmithKline Consumer Healthcare (to July 2010)Ralf dahmen, ASMI Honorary Life MemberLindsay Forrest, Reckitt BenckiserAllan Franz, Wyeth Consumer Healthcare (from Nov 2009)Max Johnston, Johnson & Johnson Pacific (to Aug 2009)Phil Lynch, Johnson & Johnson Pacific (from Sept 2009)

subCoMMittees, Panels and teaMs

asMi CoMPlaints Panel (Chair: Alan Limbury, Strategic Resolution)Marketing and ethiCs subCoMMittee (Chair: Jayne Senior, Mentholatum Australasia)

MeMbershiP serviCes subCoMMittee(Chair: Lindsay Forrest, Reckitt Benckiser)

ProMotional Monitoring Panel (Chair: Graham Gale, Consultant)

regulatory PoliCy subCoMMittee(Chair: Vacant. Ad hoc chairs: Anthea Steans, Anthea Steans Consulting; Elizabeth Ng, Bayer Healthcare Consumer Care; Ian Adams, GSK)CodeineAnalgesicsTeam(Chair: deon Schoombie, ASMI)ComplementaryMedicinesWorkingGroup(Chair: Michael Gepp, Pathway International)ManufacturingWorkingGroup(Chair: Michael Gepp, Pathway International)

otC Working grouP(Chair: Elizabeth Ng, Bayer Healthcare ConsumerCare)PaediatricCough/ColdTeam(Chair: deon Schoombie, ASMI)PharmacovigilanceTeam(Chair: Fiona dunagan, GlaxoSmithKline Consumer Healthcare)SchedulingWorkingGroup(Chair: Anthea Steans, Anthea Steans Consulting)SunscreenTeam(Chair: Kerryn Greive, Ego Pharmaceuticals)

self Care subCoMMittee(Chair: Mark Sargent, Bayer Healthcare Consumer Care)

ASMIPresidentRalf dahmen

VicePresident/Secretary

Lindsay Forrest

VicePresident/Treasurer

Trevor Norman

Chair,Marketing&EthicsSubcommittee

Jayne Senior

From below left to right:Trevor Norman, Combe Asia-Pacific Andrew Phillips, Novartis Consumer Health AustralasiaGraham Read, GlaxoSmithKline Consumer Healthcare (from July 2010)Mark Sargent, Bayer Healthcare Consumer CareJayne Senior, Mentholatum AustralasiaLeanne Spratt, MSd (formerly Schering-Plough)

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new SCheduling fraMeworKFurther public consultation resulted in a range of legislative amendments and a new scheduling framework came into effect on 1 July 2010. After pressure by ASMI the Parliamentary Secretary for Health and Ageing agreed to ASMI’s proposal for an amendment to the legislation that would make provision for an independent chairfor the new medicines scheduling advisory committee.

review of argoMThe major review of the Australian Regulatory Guidelines for OTC Medicines (ARGOM), which commenced in early 2009, is targeted for completion in december 2010. The overall objectives of the review are to ensure that the guidelines are consistent with the principles of minimum effective regulation and that they reflect current business practices for OTC medicines in Australia. The new guidelines will provide greater clarity of the requirements for more complex applications and, with this common understanding, should translate into greater predictability of TGA evaluation timeframes.

PaediaTriC Cough and Cold MediCineSASMI continued to deal with threats to therapeutic substances and categories. In October 2009, the TGA released a consultation paper following an independent expert review of the use of a wide rangeof substances used in cough and cold medicines in children.

In our submission, ASMI argued that there was no justification for additional restrictions for the use of these medicines in children aged 6-12 given the long history of safe use and based on the complete lack of evidence of any safety concerns in Australia. We expressed support for strengthened labelling and suggested an approach consistent with the NZ position, which also allows more flexibilityand clarity.

The TGA referred all substances included in the review to the National drugs and Poisons Schedule Committee (NdPSC) to review access to these substances. ASMI again argued that in the absence of any evidence of safety concerns there is no justification for further restrictions on medicines containing these substances.

We have been in regular discussions with the TGA to ensure that, in the event of any regulatory changes, adequate implementation timelines and transition arrangements are put in place. We also stressed the importance of avoiding uncertainty or alarm amongst consumers and the impact that could result from inappropriate timing of any announcements due to the seasonal nature of the category.

analgeSiCS ConTaining CodeineASMI collaborated with the Pharmacy Guild of Australia to maintain appropriate access to OTC analgesics containing codeine when rescheduling of these products was considered by the NdPSC. ASMI and the Guild jointly presented a proposal to monitor the supply of these products to the National Coordinating Committee on Therapeutic Goods (NCCTG), the body providing policy guidance to NdPSC, as an alternative to rescheduling.

Changes to the scheduling and pack sizes of analgesics containing codeine agreed at the October 2009 meeting of the NdPSC were implemented on 1 May 2010. ASMI was successful in gaining a five month extension of the implementation date and we negotiated labelling exemptions with all state and territory health departments to ensure minimum disruption to business for industry. ASMI collaborated with the Pharmacy Guild of Australia to ensure all pharmacists were familiar with the new requirements. To further facilitate the transition, ASMI worked with the TGA to develop Product Information (PI) and Consumer Medicine Information (CMI) template documents for codeine products when combined with ibuprofen, paracetamol and aspirin.

CoMPleMenTary MediCineS ASMI and the Complementary Healthcare Council (CHC) initiated a review of the terms of reference, membership and administrative procedures of the Office of Complementary Medicine/Industry Consultation Group (OICG) to further

improve its functioning. The group also determined priorities for reform which include a review of the coded indications associated with the listing system. The project is well under way and the aim is to provide greater clarity and flexibility for sponsors.

ASMI and CHC jointly, and successfully, lobbied the TGA to suspend changes that were introduced to the Electronic Lodgement Facility (ELF) without industry consultation. The changes, which impacted sponsors of products containing genetically modified and nanomaterial ingredients and practitioner-only products, caused significant disruption to routine business activities.

inCreaSing aCCeSS To MediCineSASMI is pursuing an accelerated switch (downscheduling) agenda for Australia and a position paper, “Increasing access to medicines to enhance self care”, was released to build stakeholder support. The purpose of the paper is: to highlight the importance of increased access to medicines as an essential element in the move towards greater self care; and to facilitate debate between all stakeholders with the aim of gaining support for a partnership approach in making increased access to medicines an Australian health policy objective.

ManufaCTuring ASMI identified a range of issues with the implementation of the new Manufacturing Principles and assisted the TGA in developing an effective transition plan to minimise the impact on industry. We also developed a communication strategy and supported an education program to assist sponsors in achieving compliance with the new legal obligations. We provided input into the development of guidance documents to assist industry with the interpretation and application of the PIC/S Guide in the Australian regulatory environment.

aChieveMents toWard the strategiC objeCtives of asMi

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ASMI’s Strategic Plan is available on the ASMI website. www.asmi.com.au

PharMaCovigilanCeASMI gained TGA support to modify OTC pharmacovigilance requirements in relation to reporting timeframes for serious adverse events. We continue to pursue further reform for non-serious event reporting via a new ad hoc team of industry partners. This will ensure an appropriate pharmacovigilance reporting practice across the non-prescription medicines sector.

labellingASMI prevented a fragmented and costly implementation of labelling reforms and secured agreement from the TGA to conduct a Regulatory Impact Assessment in relation to the proposal to modify the requirements for the prominence of actives on labels.

SunSCreenSASMI collaborated with ACCORd (the national industry association for the Australasian Consumer, Cosmetic, Hygiene and Specialty Products Industry) during the review of ARGOM to consolidate all the regulatory requirements for therapeutic sunscreens to improve the usability from an industry perspective.

ASMI continued to support the development of a new Australian and New Zealand Standard for Sunscreen Testing (AS/NZS 2604) which will reference the harmonised (ISO) test methods for in vivo SPF determination and in vitro UVA determination.

We have been instrumental in gaining agreement from the ISO Technical Committee 217 to develop a method for testing water resistance with a view to implementing a harmonised methodology.

TheraPeuTiC goodS/foodS inTerfaCeSIn October 2009, the then Parliamentary Secretary for Health, Mark Butler, announced a comprehensive review of food labelling law and policy. ASMI’s submission in response to the review incorporated our position in relation to the earlier Food Standards Australia New Zealand (FSANZ) consultation, P293: Health, Nutrition and Related Claims for Foods, and reiterated industry’s desire for a level playing field across the medicine/food interface.

QualiTy uSe of MediCineS (QuM)ASMI continued to provide project support for the Quality Assurance Reference Group (QARG) under contract with the department of Health and Ageing. One of QARG’s key roles is to assess the quality of CMIs, using as benchmarks the regulatory requirements and the CMI Usability Guidelines which were developed to assist sponsors in writing CMIs. The Reference Group is also charged with developing ‘core’ or template CMIs for therapeutic classes of medicines and providing advice on how these are best written and tested with consumers.

ASMI was a member of the Advisory Panel for a research project commissioned by the Pharmacy Guild of Australia under the Fourth Community Pharmacy Agreement which investigated the effectiveness of CMI. ASMI will be working with the Guild to ensure that the insights gleaned from the research translate into appropriate action plans to enhance QUM through the provision of CMI.

adverTiSing ConTrolSReforms in the area of advertising controls, including governance arrangements and complaints handling, remain a priority for ASMI and we continued to lobby Government and the TGA to initiate a review. We have responded to the Parliamentary Secretary for Health’s consultation paper “Advertising Therapeutic Goods in Australia” and look forward to participating in any subsequent reform process.

Self CareASMI has continued to build awareness of the benefits of wider self care. In numerous press releases and submissions, we have drawn attention to the fact that pressure can be taken off overstretched GPs and hospital casualty units by encouraging consumers to take greater personal responsibility for their health. ASMI has worked alongside various stakeholder groups, most notably The Pharmacy Guild and the Pharmaceutical Society of Australia, to

demonstrate to Government how quickly and efficiently a ‘minor ailments scheme’ could be introduced. This has been clearly articulated in the Guild’s impressive “Road Map” document.

However, the Government’s focus was channelled into the recommendations of the National Health & Hospital Reform Commission, most notably the need for greater federal control of hospitals. Our hope is that the new Government will soon turn its attention to implementing the recommendations of the Preventative Health Taskforce and the National Primary Health Care Strategy External Reference Group – both of which supported wider self care and a focus on preventative health.

ASMI is encouraged by the progress made by its sister organisation in the UK, the Proprietary Association of Great Britain (PAGB), which has run a high profile self care campaign and secured the support of all stakeholder groups including GPs and both major political parties.

growing MeMberShiP baSedespite all the pressures of the Global Financial Crisis, ASMI’s membership numbers have grown to record levels over the past 12 months.

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nZSMi 2009 ConferenCe, auCKland, nZ: “The Changing landSCaPe of Self Care” and aSMi/nZSMi MeeTingS

The ASMI/NZSMI Alliance was again promoted through involvement in both associations’ conferences and joint meetings. due to last minute commitments,Juliet Seifert was unable to attend the NZSMI Conference in Auckland held on15 October 2009. However, her presentation on the TGA and Regulatory Restructure was delivered by Tim Roper, NZSMI Executive director. Followingthe ASMI Annual Conference in Sydney, a joint ASMI/NZSMI Executive Meeting was held on 13 November 2009 to discuss key strategies of each associationand opportunities for joint approaches.

Tim Roper also attended the joint ASMI/NZSMI Strategic Review Meeting heldin Sydney on 5 May 2010.

wSMi board/CoMMiTTee MeeTingS

Juliet Seifert attended the WSMI Board and Committee meetings in Aventura, Florida USA on 11 March 2010. Key topics discussed included the endorsementof the WSMI White Paper on Non-prescription Medicine Modernization; renewal by the World Health Organization (WHO) of WSMI’s NGO status for the three year period 2010-2012; and future challenges to the OTC industry around the world.

The June 2010 meetings were held in dubrovnik, Croatia and attended byJuliet Seifert and deon Schoombie, then deputy Executive director of ASMI. Key discussions included: • US FdA activities regarding dextromethorphan and acetaminophen.

• Juliet Seifert updated the Board on an initiative by Health Action International (HAI) and the Medicines Transparency Alliance (MeTA) in Australia, focused around medicines promotion and industry codes of practice.

• Actions to further the issues canvassed in the White Paper developed by the WSMI Task Force on OTC Modernization.

ChPa annual exeCuTive ConferenCe: “reThinKing innovaTion”Juliet Seifert attended this annual conference, also held in Aventura, Florida USA on 11-13 March 2010.

aeSgP 46Th annual MeeTing: “ConneCTing wiTh Self-Care - The fuTure of Self-MediCaTion in The new euroPe”Juliet Seifert and deon Schoombie attended this annual meeting in dubrovnik, Croatia from 9-11 June 2010. Juliet Seifert facilitated a session on the “Changes in Product accessibility: How will the stakeholders benefit?” in which patients, medical doctors, a government authority and pharmacists were asked to share their views on how stakeholders would benefit from the changing conditions in the accessibility of non-prescription medicines.

From left to right: Juliet Seifert, then Executive director, ASMI; Ian Banks, President, European Men’s Health Forum; Colin Bradley, Head of the department of General Practice, University College Cork, Ireland; Isabelle Moulon, Head of Sector Medical Information, European Medicines Agency; Filip Babylon, President, Pharmaceutical Group of the European Union (PGEU); Linda Suydam, President, CHPA, USA

rePresenting asMi in international foruMs

asMi rePresentation on key external CoMMittees*

Advisory Committee on Non-prescription Medicines (ACNM) (from 1 January 2010, formerly MEC)ARCS Regulatory Education SubcommitteeARCS Pharmacovigilance Education SubcommitteeARGOM Review Project TeamsAustralian Food and Grocery Council (AFGC) Health, Nutrition Scientific Affairs CommitteeComplaints Resolution Panel (CRP) CMI Content Quality Assurance Reference Group (QARG)Electronic distribution Working Group (EdWG) for CMIsHealth Infrastructure Assurance Advisory Group (HIAAG)Industry Government Crisis Management Committee (IGCMC)Medicines Evaluation Committee (MEC) (until 31 december 2009, then became ACNM)Medicines Labelling GroupMedicines Partnership of Australia (MPA)National drugs and Poisons Schedule Committee (NdPSC), as alternate for industry representative National Institute of Complementary Medicines (NICM)National Medicines Policy Partnership Forum (NMPPF)National Precursor Working GroupNational Prescribing Service (NPS) Medicines Industry Liaison Group (MILG) (until disbanded in February 2010)NSW Poisons Advisory Committee (NSW PAC)NICNAS Cosmetic Advisory GroupOffice of Complementary Medicine/Industry Consultation Group (OICG)Pharmaceutical Industry Working Group (PIWG) Pharmacy Guild CMI Effectiveness Advisory Panel and Research Advisory TeamPharmacy Guild S2/S3 research groupPharmacy Guild QCPP Standards CommitteeStandards Australia Subcommittees for Sunscreens and Child Resistant ClosuresTGA Internet Site Redevelopment External Reference GroupTherapeutic Goods Administration Industry Consultative Committee (TICC)Therapeutic Goods Advertising Code Council (TGACC)Therapeutic Goods Committee (TGC) and subcommitteesTGA Office of Manufacturing Quality Complementary Medicines Technical Working GroupTGA Office of Manufacturing Quality Non-sterile Medicines Technical Working GroupUNSW Board of StudiesWorld Self-Medication Industry (WSMI) Board and its Subcommittees

*This list includes: - participation on behalf of ASMI either by an ASMI Secretariat staff member or a representative from an ASMI Member company; or - appointment of an ASMI Secretariat staff member or a person from an ASMI Member company as an ‘expert’.

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ASMI embarked on a new approach to promoting self care by successfully entering the rapidly-growing online world of social media.

The ASMI ‘Self Care for Australians’ social media initiative is now a growing consumer community and comprises a blog, as well as pages on popular social networking websites Twitter and Facebook.

Social media is a well established and growing global online phenomenon where the community can interact with each other in real time. Social networking websites like Twitter and Facebook have millions of users in Australia and across the world and provide a cost-effective and efficient way to build online communities.

Utilising social media was untested territory for ASMI and provided an opportunity for it to be one of the first peak bodies in the consumer healthcare sector to target consumers in a social media campaign.

The initial idea was developed by the Self Care Subcommittee, which was keen to widen the push to promote self care by undertaking a range of activities at a consumer or grassroots level. Previously, the bulk of the effort had been directed to advancing self care at the official or policy level.

The focus is to establish a presence for consumers interested in learning more about self care, and for practitioners and stakeholders to contribute to discussion on self care. ASMI also aims to be a credible source of information for consumers to improve health literacy and to educate the community about the importance of taking greater responsibility for personal health.

The challenge is to provide this information for consumers without becoming an advice service for specific health concerns or a platform for specific product promotion.

ASMI canvassed the opinions and experiences of its international counterparts that have embarked on their own social media campaigns, including the US-based Consumer Healthcare Products Association (CHPA). ASMI also sought legal opinion on the risks and developed a thorough list of terms and conditions for the sites.

aSMi STePS inTo SoCial Media

Social media is a huge and potentially powerful tool in the push towards greater self care.

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The cornerstone of the social media campaign is the Self Care for Australians ‘Self Care Blog’. The blog is updated with a series of articles on self care which canvass current issues and debates within the area of self care and will also feature healthcare practitioners who will contribute their knowledge and views.

ASMI will continue to grow the social media campaign and hopes that the websites will become a source of quality information that promote, and raise interest in, the importance of self care to the community.

Visit the Self Care Blog, which includes links to both Facebook and Twitter,at: www.self-care.net.au

Each new blog is promoted through the Self Care for Australians Facebook and Twitter accounts.

These two social networking platforms give consumers the opportunity to be a part of a self care community, receive updates and contribute to the self care debate. Both sites have been growing in popularity and are updated regularly with the latest health news and ASMI blogs.

ASMI can also gauge consumer reaction and learn about consumer experiences on various issues through a Facebook poll. One such poll asked consumers: “Would you visit your pharmacist as a first port of call for minor ailments (eg: coughs, colds, headaches)?” The results showed strong support for the use of pharmacists in the first instance for a minor ailment, with 59% voting affirmatively. The results were promoted across all three social media sites.

Along with the benefits of reaching consumers, the social networking sites have also provided greater links with other industry organisations, Members of Parliament and the media. For instance, on Twitter, Self Care for Australians is being ‘followed’ by the Australian Labor Party and the Liberal Party. The websites extend the voice of self care and provide an additional platform to widen the policy debate.

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By any measure, the past year has been one characterised by far-reaching change in a number of key areas that impact the way we operate and plan for the future.

Whether it’s the economy, the regulatory environment, the state of the industry or the political landscape, we have seen significant shifts that will have us examining where we fit and how we deal with this change.

At ASMI too, we have undergone our own renewal. I was delighted to accept the role of Executive director in August 2010 and to step into the very considerable shoes of my distinguished predecessor, Juliet Seifert, who stepped down to devote her time and energy to her immediate family.

I want to take this opportunity to once again convey to Juliet, on behalf of her many industry colleagues, associates and friends, our thanks and gratitude for her inspirational leadership of ASMI and its predecessor organisation over some 21 years. We have been the richer for the tremendous knowledge, insight and support she has provided.

I also express my appreciation to my colleagues who have entrusted me with the leadership position at ASMI. It is a large responsibility, and one that I approach with conviction and excitement.

There is much to be done, including dealing with important reform initiatives in the federal sphere which will mean all of us at the ASMI secretariat working tirelessly to ensure our industry is well placed to prosper and meet future challenges.

I am sure that all of us in the industry appreciate the scope of the challenges that lie ahead. In our own arena, we are dealing with a new and uncertain political climate, new personnel in key portfolios, a fundamentally restructured Therapeutic Goods Administration (TGA), and changing demands surrounding the issues of transparency and accountability affecting the industry.

exeCuTive direCTor’S MeSSage

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We will continue to engage in these issues in a forthright and positive manner and in a way that reflects our deep belief that this industry has contributed a great deal to the Australian economy and the community, and has much to offer in the future.

It would be unwise to ignore the palpable sense of anxiety that has taken hold in much of the industry over recent years as a result of what is seen as a more risk-averse approach to regulatory issues. Increasingly, it seems that justification for more restrictive outcomes is being constructed in the absence of overwhelming evidence, and in spite of the considerable cost to consumers.

One of our primary objectives will be to work towards establishing a proper risk-benefit approach to regulation of the non-prescription medicines sector, including decisions affecting the scheduling of medicines.

We have already been engaged with Commonwealth officials, consumers, fellow industry bodies and healthcare professional organisations on the initial stages of reform of the promotion and advertising of therapeutic products, and we will continue to make a positive contribution that is in the best interests of consumers and industry.

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Within the OTC sector itself, there is the ongoing challenge posed by a blurring of the lines between the various healthcare categories. Increasingly, consumers are using a mix of products and healthcare solutions from a wide range of providers – something that presents its own set of challenges in terms of regulatory compliance, industry membership and coverage.

Ultimately, if we are to be the true voice of the consumer healthcare products sector, we will need to consider how these goals are to be achieved, and what arrangement will best allow us to effectively serve those providers committed to an evidence-based approach.

As an industry, we have an enormous task in helping to raise the standard of health literacy in the community. In spite of the resources that have been devoted to this area by industry and governments over many years, it remains below acceptable norms. Official figures, which show less than half the population with the minimum skills to undertake fundamental tasks such as understanding and measuring medicines, present a significant nationwide challenge.

Issues like health literacy become critical in an environment where much more focus is being placed on preventative health and consumer self care. We strongly believe that there is considerable scope to enhance personal health, improve health budgets and empower consumers by embracing the notion of self care, in a similar manner to the United Kingdom. Along with ensuring the safety, quality and efficacy of products, we have an obligation to provide balanced and evidence-based information to support the quality use of our products.

Governments here have been slower to act. A number of recent inquiries into the health system have given in-principle endorsement of greater self care. ASMI stands ready to work in collaboration with government, GPs, pharmacists and other health professionals to see it put into practice. In particular, ASMI has been at the forefront in identifying the budget savings that would flow from even a limited scheme that encouraged consumers with minor ailments to use a pharmacist as a first port of call.

On this issue, like so many other issues in health, we don’t see it as a turf war. Some GP groups have taken us to task for advocating a course that they think would divert patients away from GPs and risk serious diseases going undiagnosed. It needs to be stressed that we see a vital role for GPs and we want to work with them to produce better outcomes for all consumers. Self care does not need to be a zero sum game.

Our approach to this and other initiatives has been to work collaboratively. We will continue to adopt that practice – broadening and strengthening links across the industry with consumers, GPs, pharmacists, allied health professionals, regulators and academics.

We will be forthright in representing this industry and proclaiming the very significant contribution it makes to the economy and the community. There are few industry sectors that are required to meet the very high standards, or to remain as responsive to consumer needs, as the medicines sector.

We will be playing our part to ensure that the fundamental strength, integrity and quality of our sector is enhanced, and its contribution recognised.

We have a large amount on our plate but we also have a committed and dedicated team of professionals who, I know, will be unwavering in their commitment to the industry.

I look forward to the challenge and I hope you will support our team as we go about these important tasks over the coming year.

deon SchoombieExecutive director

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Graham Birch, Marketing & development director* (to Aug 2010)

deidre Cox, Communications & Member Services Manager

Mary Emanuel, QUM Manager

Catherine Gwynne, Regulatory & Technical Manager – OTC Medicines

Ruth Kendon, Regulatory & Technical Manager – Complementary Medicines

Hamza Khan, Information Coordinator* (to April 2010)

Ros McColl, Office Administrator* (to Oct 2009)

Anthony O’Byrne, Advertising Services Manager (from Feb 2010)

Jane Parker, Projects & External Liaison Manager

Steve Scarff, Regulatory & Scientific Affairs director (from Jun 2010 – formerlyASMI Legal Representative)

deon Schoombie, Executive director (from Aug 2010 – formerly Scientific director &deputy Executive director)

Juliet Seifert, Executive director* (to Aug 2010)

Tracey Shenton, Accountant

Lesley Speechley, Executive Assistant/Office Manager

Janet Zanetti, Office Administrator (from Nov 2009)

* Former staff member

From left to right, standing: Janet Zanetti, Lesley Speechley, Catherine Gwynne, Ruth Kendon, Graham Birch, Anthony O’Byrne, Steve Scarff, deidre Cox, Judith BrimerFrom left to right, seated: deon Schoombie, Juliet Seifert, Mary Emanuel

Inset from left: Jane Parker, Tracey Shenton

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aSMi SeCreTariaT

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H&T*IMS Health Australia Pty Ltd*Industry Pulse*Invida Australia Pty Ltd*ISS Marketing*Lipa Pharmaceuticals Ltd*Market Reach*Media to Market*Mercurial Insights Pty Ltd*Minter EllisonNational Pharmacies*New Zealand Trade & Enterprise (NZTE)*Ogilvy & Mather Sydney*Oz Pharma Contracting & ConsultingPalin Communications*Pathway International Pty Ltd*Pharmabroker Sales Pty Ltd*Publicis Healthcare Communications Group*Reader’s digest Australia

MSd* (formerly Schering-Plough)Nestle Australia Ltd*Norgine Pty Ltd*Novartis Consumer Health Australasia Pty Ltd*Nycomed*Pfizer Australia Pty LimitedProcter & Gamble Australia Pty Ltd*Qintet Pharmaceuticals*Reckitt Benckiser*Ross Cosmetics Australia Pty Ltd*sanofi-aventis Australia New Zealand*Smith & Nephew Pty Ltd*Spirig Pharma Australia*Stirling PharmaceuticalsSwisse Vitamins Pty Ltd*Tony Ferguson Licencing Trust*Valeant Pharmaceuticals AustralasiaWyeth Consumer Healthcare Pty Ltd*

Remedies GroupSphere Healthcare Pty Ltd*Strategic Horizons*Sudler & Hennessey*Sue Akeroyd & Associates*Sylvan Health Pty Limited*Synovate AztecTechnical Consultancy Services Pty Ltd*The Coaching CompassThe Nielsen Company (Australia) Pty Ltd*Thomsons Lawyers* TorchMedia*Touchstone Consulting Executive SearchUBM Medica*Ultrafeedback Pty Ltd*URSA Communications*Ward6*Xena Technologies Pty Ltd*

* denotes current Members (list correct at time of printing)

OrdinaryMembersAllergan Australia Pty Ltd*Aspen Pharmacare*Baxter Laboratories*Bayer Healthcare Consumer Care*Biological Therapies Pty Ltd*Boehringer Ingelheim Pty Ltd*Church & dwight Australia*Combe Asia Pacific Pty Ltd*Ego Pharmaceuticals Pty Ltd*Ensign Laboratories Pty Ltd*Flordis Pty LtdGalderma Australia*GlaxoSmithKline Consumer Healthcare*Hamilton Pharmaceutical Pty Ltd*H W Woods Pty Limited*Johnson & Johnson Pacific Pty Ltd*Link Medical Products*Mentholatum Australasia Pty Ltd*

AssociateMembersAgilent Technologies Australia Pty LtdAnthea Steans Consulting Pty Ltd*Archer Emery & Associates*Australian Pharmaceutical Publishing Co. Pty Ltd (APPco)*AZPA InternationalBASF Australia LtdBest Practice Consultants*Catalent Pharma Solutions*Cegedim dendrite Australia Pty Ltd*CJB*Clare Martin & Associates*Contract Pharmaceutical Services of Australia P/L*Corrs Chambers Westgarth*Crossmark*Cube*Cynergy SearchdHL Supply Chain (Australia) Pty Ltd*Engel, Hellyer & Partners Pty Ltd*Euro RSGC Life*

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MembersofASMI2009/2010

HonoraryLifeMembersMr R dahmenMr K darkeMr A d Gloverdr W A MorganMr d C Murphydr J PentecostMr d StephensMr C J TuckerMr A J WardellMr W J Wilkinson AO

asMi annual aWards and ConferenCe

ASMI2009ConferenceA record number of around 330 delegates from across the OTC sector attended ASMI’s Annual Conference “Self Care: How Much Is Your Responsibility?” at the Australian Technology Park in Sydney on 12 November 2009.

Representatives from OTC and complementary healthcare companies, pharmacy groups, industry associations and government listened as local and international experts discussed current issues and concerns within the sector including regulatory “creep” and risk assessment, and the responsibilities of key stakeholders in achieving a broader self care environment.

Highlights included:The event was opened by Federal Health Minister, The Hon. Nicola Roxon MP [pictured below right]. The Hon. dr Craig Emerson MP [pictured below left], Minister for Small Business, Independent Contractors & the Service Economy; Minister for Competition Policy & Consumer Affairs; Minister Assisting the Finance Minister on deregulation presented on Healthcare Reform & Striking the Right Regulatory Balance

The ABC’s dr Norman Swan moderated a panel session: “What Will Self Care Look

Like? Why Is It In the Public Interest to Promote Wider Self Care? What Is the Responsibility of Each Key Stakeholder to Ensure That Self Care delivers desired Outcomes?” Panellists were: Carol Bennett, Executive director, Consumers Health Forum of Australia; Mario Capanna, Managing director, Cincotta Chemist; dr Tony Hobbs, formerly Chair of the National Primary Health Care Strategy External Reference Group; Professor Stephen Leeder, director, Menzies Centre for Health Policy (MHCP); and dr Linda Suydam, President, Consumer Healthcare Products Association, ASMI’s sister association in the US.

A second panel, also moderated by dr Swan, discussed: “How Should Industry & Regulators Cooperate to Unleash the Potential of Self Care?” with panellists: Professor

Alan Bensoussan, Executive director, National Institute of Complementary Medicine (NICM); Odette Gourley, Partner, Corrs Chambers Westgarth; dr Ken Harvey, Adjunct Senior Research Fellow, School of Public Health, La Trobe University; Chris Horsey, Head of Better Regulation, department of Health (England);Steve Mann, Marketing

director, sanofi-aventis Consumer Healthcare; and Michael Smith, Head of the Office of Complementary Medicines, Therapeutic Goods Administration (TGA).

Another highlight was the inspirational story of Mao’s Last Dancer, Li Cunxin. Li’s extraordinary life story had been released as a film, based on his bestselling book, only a month before the event. To the delight of delegates, Li stayed on after his presentation to sign copies of his book.

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Life Education Van OnsiteOnce again, the Life Education Van was onsite for delegates to take a tour and experience some of the interactive materials that make up the Mind Your Medicine Program.

Co-funded by ASMI, Mind Your Medicine educates children in their 4th and 5th year of schooling about the names, safe use, storage and effects of medicines on the body, as well as issues such as effective communication skills, bullying and friendship.

More information on this partnership can be found at: http://www.asmi.com.au/self-care/ASMI-and-Life-Education.aspx

Sales&MarketingAwardsThe 2009 ASMI Sales & Marketing Awards winners were presented at the Conference dinner by the Parliamentary Secretary to the Minister for Health & Ageing, The Hon. Mark Butler MP. The Awards dinner was hosted by Simon Corah of Growth Mantra, who was also an Awards Judge.

These Awards acknowledge excellence in the sales and marketing of OTC/complementary healthcare products, innovation, marketing and sales best practice, and consumer focus, as well as recognising the importance of the Quality Use of Medicines (QUM).

The Awards Judging Panel was made up of a consumer representative, a pharmacist, the Managing director of a major healthcare advertising agency (which did not have an entry in the Awards) and a pharmacy journalist.

The winners were selected based on clarity of the business objective, attention to Quality Use of Medicines, results achieved, the degree of challenge in the marketplace, creativity and innovation. A new category – Best PR Initiative – was also introduced in 2009.

Best Launch of a Consumer Healthcare ProductListerine Total CareJohnson & Johnson

Best Advertising/Promotional Campaign (incl. Relaunch) for an Existing Consumer Healthcare ProductCanestenBayer Australia

Best Self Care ProgramSomacNycomed

Best Sales Force Initiative – Grocery and/or Pharmacy2009 Pharmacy Winter Sell-in KitReckitt Benckiser

Best PR InitiativeManage Pain (Codeine Education Program)Reckitt Benckisera

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The TyPeS of non-CoMPlianCe ConCernS idenTified aS a PerCenTage of all breaCheS: • 81% were for lack of mandatory statements or mandatory statements that were not prominently displayed (“Always read the label”; “Use only as directed”; “If symptoms persist consult your healthcare professional”; “Your pharmacist’s advice is required”), in breach of TGAC clause 6.3 • 5% were for misleading information and exploiting the lack of knowledge of consumers, in breach of TGAC clauses 4.2(c) and 4.2(d) • 7% included a reference to a serious condition, in breach of TGAC clauses 5.1 or 5.2 • 3% implied other products may be harmful, in breach of TGAC clause 4.5 • 2% advertised offers of samples, in breach of TGAC clause 4(8) • 2% did not contain the indication for the product, in breach of TGAC clause 6(3)(b)

Compliance with the ASMI Code of Practice was also very high. Non-compliance issues related only to lack of compliance with the TGAC as listed above, which is a breach of clause 4.3.1 ofthe ASMI Code.

outCoMes of ProMotional Panel revieWs

The aiMS of ThiS ProCeSS are To: • monitor and report on advertising which is not subject to pre-approval• improve compliance with the TGAC and ASMI Code of Practice• demonstrate industry’s capacity to self-regulate

The Promotional Monitoring Panel is independent of the ASMI Complaints Panel and is responsible for proactively monitoring and reporting on non-compliant below-the-line advertising and recommending remedial actions.

The Panel is comprised of an independent Chair, a pharmacist from the Pharmaceutical Society of Australia, a consumer representative from CHOICE, the ASMI Advertising Services Manager, the ASMI Marketing & development director and industry representatives volunteering from Member companies in non-competing categories. Thank you very much to this team for their time and commitment to making this process successful and relevant to the needs of the industry.

The Panel met four times between 1 July 2009 and 30 June 2010 (4th meeting actually held on 9 July 2010) to review ‘below-the-line’ advertising materials of Member companies for compliance with the TGAC and the ASMI Code of Practice.

ProMoTional MaTerialS SeleCTed for review: • Analgesics • Antiseptics • Cough & cold products • Weight loss products • Eye/ear products • Gastrointestinal & Urinary • Complementary - women’s health • dermatological conditions • Complementary - memory & learning, stress relief, stimulants & awakeners • Media releases across all categories

findingS:A total of 443 items were reviewed, of which 94 were found to contain one or more possible breaches of the ASMI Code of Practice and the TGAC. Most of the breaches were the same breach repeated by the same company within the same campaign. The overall level of non-compliance was low with the majority of sponsors having fully compliant promotional material.

CoMPlaint 1Dateofdetermination: 23 Nov 2009Complainant: Hamilton Laboratories (“HL”)Respondent: Johnson & Johnson Pacific (“JJP”)Particulars: Advertising in relation to Neutrogena Ultra Sheer dry-Touch Sunscreen Lotion, directed to Healthcare Professionals published in the Australian Journal of Pharmacy. The advertising contained a graph, said to show “UVA efficacy”, depicting ten products, three of which, including one identified as “helioplex®”, were coloured yellow and described as “Photostability PASS”. The other seven, including HL’s Opti SPF 30+ 4 hrs water resistant sunscreen (“the HL product”), were coloured blue and described as “Photostability FAIL”.

AllegedBreaches:Clauses 5.1.3, 5.2.2 and 5.4.1 of the ASMI Code.

Outcomes:The Panel found that the footnotes to the graph in question did not effectively qualify the representation made by the graph that all the products depicted were tested according to the same standard, i.e. on 10 subjects for each product, and that, in the case of the HL product (which was tested on 3 subjects), the SPF derived from such testing was lower than its label claim, hence in underperforming its label claim the product “failed”, i.e. was ineffective. This was sufficient to find the advertisement in breach of clause 5.1.3 in that it was misleading and not based on facts which had been previously substantiated and in breach of clause 5.2.2 in that it described or showed the HL product as ineffective. These breaches were Moderate breaches. The Panel found that in relation to clause 5.4.1, the failure to include the minimum requirements for an advertisement to Healthcare Professionals, as admitted by JJP, was a minor breach.

Sanctions:The Panel required JJP to: • Cease publication in any media, until it can be supported by clinical evidence, properly conducted, of any claim to the effect that the SPF of any sunscreen product is less than its label claim; • Cease publication in any media of the results of any SPF test not conducted fully in accordance with the AS/NZS 2604:1998 standard “Sunscreen Products – Evaluation and Classification” or any standard replacing that standard from time to time; • Publish a retraction statement in the Australian Journal of Pharmacy; and • Pay a fine of $20,000 for the Moderate breach.

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CoMPlaint 2Dateofdetermination: 29 dec 2009Complainant: Ego Pharmaceuticals Pty Limited (“Ego”)Respondent: Johnson & Johnson Pacific (“JJP”)Particulars: Advertising in relation to Neutrogena Ultra Sheer dry-Touch Sunscreen Lotion, directed to Healthcare Professionals published in Australian Pharmacist and in the Australian Journal of Pharmacy (“the HCP advertisement”). Advertising in relation to Neutrogena Ultra Sheer dry- Touch Sunscreen Lotion, directed to consumers published in Australian Women’s Weekly and Madison magazine and a television commercial (“the consumer advertisement”).

AllegedBreaches:In relation to the HCP advertisement: clauses 5.1.3, 5.1.4 and 5.2.2 of the ASMI Code.

In relation to the consumer advertisements: clauses 5.1.3 and 5.2.2 of the ASMI Code.

Outcomes:Procedural issuesThe Panel noted that a complaint had been lodged with the Complaints Resolution Panel (CRP) concerning the consumer advertisements. The Panel, therefore, refrained from determining the issues that were already the subject of the complaint lodged with the CRP and accordingly considered only the HCP advertisement and only insofar as the issues were not replicated in the CRP complaint. The Panel noted that the HCP advertisement was the subject of an earlier complaint by Hamilton Laboratories (“the HL complaint”), determined by the Panel. Some aspects of Ego’s complaint were addressed in the HL determination. Others were not.

The post immersion SPF of Neutrogena Ultra Sheer Dry-Touch Sunscreen LotionThe HCP advertisement included a post immersion SPF score of 86 for the Neutrogena product.The Panel found that JJP’s initial testing did not substantiate the claimed post immersion SPF of 86 because that testing was not conducted on 10 eligible subjects, as required by the Australian standard. The Panel found that the advertisement was misleading and in breach of clauses 5.1.3 and 5.1.4 because the claim had not been substantiated at the time of the publication of the advertisement. These breaches were Moderate breaches.

Comparative advertisingThe HCP advertisement included post immersion SPF test results for competitor sunscreens.The Panel found that testing of the competitor sunscreens had been conducted by JJP on only 3 subjects, contrary to the requirement of the Australian standard of 10 subjects. The Panel

outCoMes of CoMPlaints lodged under the asMi Code of PraCtiCe july 2009 to june 2010

found that the footnotes to the graph in question did not effectively qualify the representation made by the graph that all the products depicted were tested according to the standard (i.e. on 10 subjects for each product) and that, in the case of the Ego products, the SPF of 30 derived from such testing (i.e. not more than 30) was lower than their label claims of 30+ (i.e. 31 or greater), hence in underperforming its label claim the product “failed” (i.e. was ineffective). Accordingly, the advertisement was found to be in breach of clause 5.1.3 in that it was misleading and not based on facts which had been previously substantiated and in breach of clause 5.2.2 in that it described or showed the Ego products as ineffective. These breaches were Moderate breaches.

The use of test methods by JJP that are not in the AS/NZS 2604:1998The HCP advertisement included results for photostability and UVA protection generated using test methods that were not in the Australian standard. The Panel did not consider it a breach of the Code to use testing methods other than the Australian standard for determining photostability and UVA protection. Whether the methods used by JJP reflected the current body of scientific evidence and were reliable was considered by the Panel below. This aspect of the Complaint was dismissed.

Photostability Pass/Photostability FailThe HCP advertisement described the test used to support these claims as “COLIPA in vitro method for determination of Photostability of Sunscreens”. This did not accurately describe the method used. The Panel found that it was misleading to refer to a non-existent method of testing. The wording of the footnote represented that the (non-existent) method was a test for photostability generally and was not confined to photostability in UVA. Having regard to the way in which the graph was presented, the words “UVA efficacy” would not necessarily be interpreted as applicable to the references to photostability, thus leaving the reader with the understanding that the sunscreens that fail were ineffective in other respects. The Panel accepted that the COLIPA method used by JJP was controversial and was not satisfied that there existed a general scientific consensus that the method was reliable. It followed that the “pass”/“fail” claims had not been substantiated. In this respect the advertisement breached clauses 5.1.3 and 5.2.2. These breaches were Moderate breaches.

Breakdown of sunscreensThe HCP advertisement included a graph which depicted seven “sunscreens that break down after 1hr”. The Panel found it likely that readers would take the “break down after one hour” claim as referring to SPF as well as to photostability. Accordingly, the claim was misleading and in breach of clauses 5.1.3 and 5.2.2. These breaches were Moderate breaches.

In vivo UVA efficacyThe HCP advertisement included a graph depicting “in vivo UVA scores”. These scores were generated using a test described as “JCIA for UVA protection factor (PFA)”. This is a Japanese test method not included in the Australian standard. The Panel did not consider it a breach of the ASMI Code to use test methods other than the Australian standard for determining UVA protection. The JCIA method did appear to reflect the current body of scientific evidence. This aspect of the Complaint was dismissed.

“…up to 4 hours”The HCP advertisement included the statement “…providing…long lasting UVA protection, for up to 4 hours”. The Panel found that pharmacists would be likely to understand all the references in the text to “up to 4 hours”, including the reference to UVA protection (without water immersion), as “for 4 hours” and further to be likely to understand the advertisement as a whole to represent that the Neutrogena product provides 4 hours UVA protection with or without water immersion for 4 hours. This was misleading and unsubstantiated and in breach of clauses 5.1.3 and 5.2.2. These breaches were Moderate breaches.

No visible AUST L number The HCP advertisement did not refer to the product’s AUST L number. The Panel found that there was no requirement for the advertisement to display AUST L numbers. This aspect of the Complaint was dismissed.

Sanctions:The Panel took into account the determination in the HL complaint and required JJP to: • Cease describing the COLIPA 2007 Guideline “Method for the in vitro determination of UVA protection” as the “Colipa in vitro method for determination of UVA Protection provided by Sunscreens”; • Cease publication in any media of any comparison of sunscreen products based on results obtained by the application of the COLIPA 2007 Guideline “Method for the in vitro determination of UVA protection”; • Cease publication in any media of any claim, until it can be supported by scientific evidence, properly conducted: - that a competitor’s sunscreen breaks down after 1 hour; - that a competitor’s sunscreen is ineffective; - that Neutrogena Ultra Sheer dry-Touch Sunscreen Lotion provides 4 hours UVA protection; - that Neutrogena Ultra Sheer dry-Touch Sunscreen Lotion provides 4 hours UVA protection with water immersion for 4 hours; and • Publish retraction statements in both Australian Pharmacist and the Australian Journal of Pharmacy.

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CoMPlaint 3Dateofdetermination: 29 Apr 2010Complainant: Nycomed Pty Ltd (“Nycomed”)Respondent: Bayer Australia Limited (“Bayer”)Particulars: Advertising in relation to Citracal calcium citrate tablets, directed to pharmacists in a “leave behind” detailer; to consumers and healthcare professionals (“HCPs”) on a website; and to pharmacy assistants in a “Contact” training manual, a Pharmacy News publication.

AllegedBreaches:Clauses 5.1.3, 5.1.4 and 5.2.2 of the ASMI Code.

Outcomes:“Compared to calcium carbonate” The Panel found that this statement appeared only in qualification of the “harder working” and “superior absorption” claims and it was inappropriate to consider them as a stand-alone statement. This aspect of the Complaint was dismissed.

“Citracal has superior absorption by about 25% compared to calcium carbonate” The Panel found support for the “about 25%” claim. This aspect of the Complaint was dismissed.

“CITRACAL. THE HARDER WORKING CALCIUM*. * Compared to calcium carbonate”. The Panel found that the words “the harder working calcium” would be understood by reasonable consumers and reasonable HCPs alike as a representation of superior clinical effect to calcium carbonate and many may be left with the impression that because of its superior absorption, Citracal has the superior effect to which the representation refers. The Panel found this claim to be in breach of clauses 5.1.3 and 5.1.4 and the breach to be a Moderate breach.

Graphic comparing femur bones after taking Citracal or calcium carbonate The Panel found that taken in the context of the advertisement in question in each case, and having regard to the associated text, the graphic was likely to convey to consumers that 100% calcium is absorbed from Citracal and that only 75% of the calcium is absorbed from calcium carbonate products in the Australian market. Further, the “missing” portion of bone was likely to convey to consumers that those calcium carbonate products were ineffective. HCPs would have no different understanding of the graphic. Since these representations were untrue, the graphic breached clauses 5.1.3 and 5.2.2. The breaches were Moderate.

Absorption fraction graphic adapted from Levenson et al, 1994 The Panel found that in describing the graph appearing in its advertising as “Adapted from Levenson et al 1994”, Bayer had misrepresented its source. Although inversion of the curve was permissible, Bayer’s adaptation of the graph was inaccurate and in breach of clause 5.1.3. This was a Minor breach.

“Citracal + D meets vitamin D RDI at any age group unlike other calcium supplements”“Because Citracal® + D contains 12.5 micrograms of vitamin D3, it is one of the only calcium-D supplements which contains enough vitamin D to meet the recommended daily intakes for all age groups”.The Panel found the statement “Citracal + d meets vitamin d RdI at any age group” to be correct because it was likely to be understood as referable to the dosage of 1-2 tablets per day, not to a single tablet. This aspect of the Complaint was dismissed. The Panel found that the statement “unlike other calcium supplements” breached clause 5.1.3 because, in its context, it was likely to be understood as referring to all other calcium supplements available in Australia. So understood, it was incorrect because other supplements did meet vitamin d RdI at any age group at their prescribed dosage. This was a Moderate breach. The Panel found that the second statement (which appeared on the website) did not represent that one tablet met the vitamin d RdI at any age group and did not claim to be the only calcium supplement to do so. This aspect of the Complaint was dismissed.

“Citracal (calcium citrate 250mg) Citracal + D (calcium citrate 315mg/vitamin D 500IU)” The Panel found that this statement breached clause 5.1.3 because the figures used referred to elemental calcium, not, as stated, to calcium citrate. The figures on the pack shots were insufficiently legible and insufficiently prominent to correct the misstatement. This was a Minor breach.

Sanctions:The Panel required Bayer to: • Cease forthwith the publication of the following in any media, including on any website, until they can be supported by clinical evidence, properly conducted: - the words, in connection with Citracal or Citracal + d: “THE HARdER WORKING CALCIUM* *compared to calcium carbonate”; - any representation that Citracal has superior clinical effect to calcium carbonate; - the graphic comparing femur bones after taking Citracal or calcium carbonate; - any representation that 100% of the calcium is absorbed from Citracal; - any representation that 75% of the calcium is absorbed from calcium carbonate products in the Australian market; - any representation that calcium carbonate products are ineffective; - the absorption fraction graphic said to be adapted from Levenson et al, 1994; 19

- the statement “unlike other calcium supplements”, when used in conjunction with the statement: “Citracal + d meets vitamin d RdI at any age group”; - the statement in relation to Citracal: “calcium citrate 250mg”; - the statement in relation to Citracal + d: “calcium citrate 315mg/vitamin d 500IU”; • Retrieve and destroy all “leave behind” detailers containing any such claims; • Publish on the Home page of its website at <www.citracal.com.au> and on the Home page of any other relevant website a Corrective Statement and to maintain that statement continuously on each such page for a period of six months; • Publish a retraction statement in Pharmacy News; and • Pay a fine of $10,000 for the Moderate breaches found by the Panel.

CoMPlaint 4Dateofdetermination: 26 May 2010Complainant: Wyeth Consumer Healthcare Pty Limited (“Wyeth”)Respondent: Bayer Australia Limited (“Bayer”)Particulars: Advertising in relation to Citracal calcium citrate tablets, directed to pharmacists and to consumers in a “bottle neck tie”, a “pharmacy leave behind piece”, a “booklet”, a “leaflet”, a “pharmacy assistant training manual” and on a website.

AllegedBreaches:Clauses 4.3.1, 5.1.3, 5.2.1 and 5.2.2 of the ASMI Code.

Outcomes:“Citracal is the harder working calcium* *compared to calcium carbonate” (“Harder Working Claim”)The claim was found in breach of the ASMI Code of Practice in Nycomed v. Bayer, 29 April, 2010 (“the Nycomed case”) and remedial action was required by the Panel. It was therefore unnecessary for the Panel to consider this claim.

“Citracal + D meets vitamin D RDI at any age group” (“RDI Claim”)The claim was dismissed in the Nycomed case and, for the same reasons, the Panel dismissed the complaint about this claim.

“Citracal delivers the optimal dose of calcium” (“Optimal Dose Claim”)The Panel found that this claim was likely to be understood as referable to the dosage of 1-2 tablets per day, not as a claim for a single tablet and as such, the claim was substantiated. Accordingly, the Panel dismissed the complaint about this claim.

“Citracal is absorbed by about 25% better than calcium carbonate to help promote bone density, build strength and prevent fractures” (“Bone Density Claim”)The Panel found that this claim implied superior efficacy due to superior absorption and that there was no evidence that calcium citrate was more effective than calcium carbonate in promoting bone density, building strength and preventing fractures. The Panel therefore found this claim to be inaccurate and misleading and in breach of Clauses 5.1.3, 5.2.2 and 4.3.1, the latter on the basis that it fails to comply with clauses 4(1)(b), 4(2)(c) and 4(5) of the TGAC. The breach was a Moderate Breach.

“Citracal has superior absorption by about 25% compared to calcium carbonate” (“Absorption Claim”)Although this claim was dismissed in the Nycomed case, the Panel in this case was provided with additional studies and commentary not provided to it in the Nycomed case. The Panel considered all the studies on which the parties relied and their detailed and comprehensive comments on them. The Panel found the studies inadequate to support the Absorption Claim. The Panel therefore found the claim to be inaccurate and misleading, in breach of Clauses 5.1.3, 5.2.2 and 4.3.1 of the ASMI Code, the latter on the basis that it fails to comply with clauses 4(1)(b), 4(2) (c) and 4(5) of the TGAC. The breach was a Moderate Breach.

Sanctions:The Panel took into account the determination in the Nycomed case, and required Bayer to:

• Cease forthwith the publication of the following in any media, including on any website, until they can be supported by clinical evidence, properly conducted:

- the words “Citracal has superior absorption by about 25% compared to calcium carbonate” and any representation to like effect; - the words “Citracal is absorbed by about 25% better than calcium carbonate to help promote bone density, build strength and prevent fractures” and any representation to like effect; and

• Retrieve and destroy all Pharmacy leave behind pieces and all leaflets containing any such claims.

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asMi: rePresenting the australian ConsuMer healthCare industryASMI is the peak body representing companies involved in the manufacture and distribution of non-prescription consumer healthcare products in Australia. ASMI also represents related businesses including advertising, public relations, legal, statistical and regulatory consultancy companies and individuals.

Our purpose is to represent the best interests of our Members through negotiation, debate and co-operation with a wide range of stakeholders in our own region and around the world. We also gather the best current information and intelligence from diverse sources and disseminate it to our Members to alert them to potential issues that may affect their products and their markets.

ASMI is a member of the World Self-Medication Industry (WSMI) and our President, Ralf Dahmen and Deon Schoombie, our Executive Director, sit on the Board of that organisation. WSMI is a non-government organisation (NGO) made up of over 50 member associations located on all continents of the world and with affiliation to the World Health Organization (WHO). Our membership of WSMI enables us to track and contribute to international trends and developments in consumer healthcare.

asMi visionBetter health through responsible Self Care

asMi MissionASMI - the voice of the consumer Self Care products industry, driving a credible and expanding evidence-based self-medication market to generate cost-effective health solutions and improved public health outcomes.

asMi values• Drivers of change through Member contribution and industry interaction. • Best practice in governance and service. • Committed to representation by consumers, relevant industry sectors and healthcare professionals.• Consistent in policy and action.• A learning organisation committed to competency development.

PMS CMYK

C R E AT I V E


PMS 129 PMS 382PMS 072 PMS 072 (50%)



australian self MediCation industry inC

abn 55 082 798 952

level 22, 141 Walker street, north sydney nsW 2060

Po box 764, north sydney nsW 2059

Ph +61 2 9922 5111 fax +61 2 9959 3693

[email protected]

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C R E AT I V E


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