submission to the accc inquiry into grocery prices - australian self-medicatio… · the maximum...

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To: [email protected]

Grocery Prices submission to the ACCC Inquiry

Dear Inquiry

The Australian Self-Medication Industry is pleased to provide the attachedsubmission for your inquiry.

If you wish to have further advice or information, please contact me.

Yours faithfully

Juliet SeifertExecutive Director

GROCERY PRICES

Submission to the ACCC Inquiry

by

Australian Self-Medication Industry

March 2008

Submission to the ACCC Inquiry into Grocery Prices

SUBMISSION BY AUSTRALIAN SELF-MEDICATION INDUSTRY ii

Contents

Executive Summary iii

This submission 1

The Therapeutic Goods market 1

Regulation and classification of medicines 1Registered or Listed? 1Scheduling of “poisons” 2GST 2“Switching” 3

Competition in the medicines market 3

Responsible self-medication: self-care 4

GST 4

Conclusions and Recommendations 5

Submission to the ACCC Inquiry into Grocery Prices

SUBMISSION BY AUSTRALIAN SELF-MEDICATION INDUSTRY iii

Executive Summary

Australian Self-Medication Industry (ASMI) represents themanufacturers and sponsors of non-prescription medicines in Australia.The industry has an annual turnover of about $2bn.

Recognising that the main focus of the inquiry is on food prices, thissubmission briefly outlines the regulatory and taxation issues affectingthe sale of medicines. ASMI is happy to provide further advice orinformation if required.

The “scheduling” of medicines controls what may be sold outsidepharmacies. “Unscheduled” medicines largely include low-riskproducts which people buy to help with the treatment of commonailments.

ASMI believes that the competition issues in respect of “unscheduled” medicines are similar to those in the food and othergrocery/supermarket outlets.

Competition will be enhanced in the medicines market if-

- there is the widest possible access to “over-the-counter” medicines, consistent with the principle of responsible self-medication; and

- there is a recognition among public health policy-makers that readyaccess to self-medication will advance the Government’s emphasis on preventative rather than curative healthcare.

There is an opportunity to reduce the cost to working families of theirmedicines if the GST did not apply to any medicine listed on theAustralian Register of Therapeutic Goods.

The regulatory regime for OTC medicines should be reviewedconsistent with the maintenance of public health and safety.

SUBMISSION BY AUSTRALIAN SELF-MEDICATION INDUSTRY 1

This submission

This submission to the ACCC inquiry into grocery prices is from the Australian Self-Medication Industry (ASMI). ASMI represents Australian manufacturers andsponsors of non-prescription medicines.

At Attachment 1 is some background information about ASMI, its membership and itspolicy objectives. Further information or clarification could be provided if required.

The Therapeutic Goods market

As set out in more detail below, Australian therapeutic goods regulatoryarrangements allow some non-prescription medicines to be sold in outlets other thanpharmacies. This category of goods will usually appear on supermarket or storeshelves near or with “personal care” products, many of which are regulated as cosmetics1 rather than as“therapeutic goods”.2

Total annual turnover of non-prescription medicines is $2.3 bn. Products not sold inpharmacies account for $.06 bn, or 38% of this market.

ASMI represents manufacturers and sponsors of two broad categories of medicines:

“Over-the-counter” (OTC) –mainly proprietary pharmaceutical lines and morelikely to be sold in pharmacies only; and

“Complementaries” –vitamins, minerals and herbal supplements–soldvariously in health-food stores, pharmacies or grocery-supermarket.

Regulation and classification of medicines

Registered or Listed?

The Therapeutic Goods Act (“the Act”) allows medicines to be approved for sale by means ofentry on the Australian Register of Therapeutic Goods (“ARTG”) either as

a Registered product3; or

a Listed product.4

In both cases, goods must satisfy safety and quality standards. In addition, AUST Rgoods must meet stringent efficacy requirements; AUST L goods must hold efficacydata for checking in the event their therapeutic claims require testing.5

1 See Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.

2 Therapeutic Goods Act, Regulations and related Legislative Instruments.

3 AUST R appears on the label.

4 AUST L appears on the label.

5 This will usually happen if someone makes a complaint about claims made in an advertisement. The Complaints Paneland/or the TGA may then requisition the efficacy data and assess its validity.


Scheduling of “poisons”

Under a complex Commonwealth-State regulatory scheme, the National Drugs andPoisons Schedule Committee (NDPSC) draws up a Standard for the UniformScheduling of Drugs and Poisons (SUSDP). It classifies substances into Scheduleswhich limit access to stated categories of supplies. The higher the Schedule, themore restricted the access.

Substances which are medicines are classified in Schedules 2, 3, 4, 8 and 9, areshown in the box.

Medicine Schedules

S9–Prohibited drugs

S8–Dangerous/restricted drugs

S4–Prescription-only supply

S3–May only be sold by a pharmacist

S2–May only be sold in/from a pharmacy

Unscheduled–Open sale (“GSL”)

All scheduled medicines must be registered (AUST R). It follows that S4, S3 and S2products must be sold in pharmacies only. On the other hand, a few unscheduledproducts are also required to be Registered–notably analgesics in small packs.These can be sold in open sale, but larger pack sizes remain a pharmacymonopsony.

GST

GST has been payable on some medicines, but not others, since the legislation wasfirst enacted. The following table summarises the present situation.

GST on medicines

GST-free

Pharmacy: S4, S3 and S2 medicines

GSL: Unscheduled small-pack analgesics(Aspirin, Paracetamol, Ibuprofen)

Sunscreens SPF15+

Folate supplements (not includingiron)

Tampons*

Nicotine-based smoking cessationproducts

GST payable

All other unscheduled products,e.g.-

Vitamins

Minerals

Herbals

Cough/cold preparations

Mouth washes

Dermatologicals

Disinfectants

Hair treatment products

Note: Tampons are classified under the Act as “devices” and are thus strictly speaking not medicines


The list of unscheduled products which are GST-free has no rational basis. Thereare many unscheduled products which provide at least as many public healthbenefits as do those in the short list in the box. ASMI has always proposed that allproducts on the ARTG should be GST-free, irrespective of what restrictions onaccess any of them may attract.6

“Switching”

From time to time, the NDPSC decides that certain substances may be down- or up-scheduled. Thus a prescription medicine (S4) may be re-scheduled as OTC (S3) oran S3 to S2. Importantly for the present enquiry, it is not unknown for scheduledsubstances to be de-scheduled. At that point, products become eligible for lawfulsale in non-pharmacy outlets.

The most recent notable cases of de-scheduling were

down-scheduling of small-pack ibuprofen, so that this product then competedwith aspirin and paracetamol; and

down scheduling of smoking-cessation products (one might imagine these asnow competing with cigarettes).

In both these cases, it was necessary for the sponsors to go through an arduousprocess to obtain the agreement of the nine governments party to the GSTAgreement to the grant of GST-free status.

ASMI considers that, at the very least, a product which is down-scheduled toGSL should automatically retain its GST-free status; and that the legislationshould be amended accordingly.

Competition in the medicines market

We apprehend that those medicines in respect of which pharmacy enjoys aregulatory-imposed monopsony, are outside this inquiry’s terms of reference. As is implicit in the account of regulatory and tax arrangements given above, however,down-scheduling of some products, and/or reform in the GST regime, could affect themix of factors influencing the prices of some products. ASMI is unable to speculateon the exact probable effects. Much of the relevant information is not in the publicarena or known to our membership. Also, the market effects of various changes thatmight be envisaged could vary greatly, depending on the products in question.

As for products that are now unscheduled, ASMI notes that their situations insupermarkets and the like are comparable with those of foods, cosmetics, householdcleaners and other products. The competition is between brands; ASMI member-companies compete for shelf-space and reach arrangements with retailers inaccordance with their own commercial priorities.

Our members have noted, however, a tendency to develop “house” brands by the larger supermarket chains. This practice inevitably drives down wholesalers’ margins. A point could be reached where well-known medicine brands might

6 See p.4 below.


disappear from the market, including from supermarket shelves, simply becausecontinuing supply for the prices offered will be uneconomic.

This inquiry will no doubt consider whether this degree of vertical integration helps orhinders competition and thus whether it keeps prices lower or drives them higherthan would otherwise be the case.

Responsible self-medication: self-care

ASMI has always advocated the minimum regulation necessary to protect publichealth and safety and maximum public access to our products to promotecompetition. ASMI would like to see the regulatory authorities take a less risk-averseapproach to their decisions about access. We would like to see formal processes inplace designed to assess risk against benefits. The latter should include, in our view,not just medicinal efficacy, but also amenity and convenience for the consumer andthe maximum opportunity for competition in a market with the least practicableregulation.

In keeping with these principles, ASMI has developed, together with like-mindedindustry groups overseas, the idea of self-care. The detailed elements of thisapproach are set out in our policy paper, reproduced at Attachment 2.

The Government’s policy approach to health is consistent with a greater emphasis than in the past on a preventative approach. That is, the maintenance of wellnessrather than the curing of illness should be the first line in public health policy. In thisapproach, people’s access to medicines includes access to a wide range of products which are offered to the public to avoid or avert illness. ASMI considers that it is inthe interests of public health and wellness for the maximum access and greatestcompetition to obtain.

ASMI’s studies of consumer attitudes, and our members’ own commercial experience, confirm that consumers of medicines are very conscious of the choicesthey make. They are neither children nor fools. Often these decisions rest with thefemale leader in the family. Typically, she will have relied on a wide range of sourcesof information in making the family’s self-care choices. These include the familydoctor and the local pharmacy, but extend more broadly these days to the internet,lifestyle magazines (“advertorials”) and straight-out advertising (in all media), notforgetting word of mouth.

ASMI believes that the COAG Principles on Good Regulation should apply with equalforce to the regulation of medicines. That is, it should be for the authority proposingthe restriction on competition to show why it is needed; not on the business affectedto show why it is not. As well, rigorous cost/benefit assessment should be applied inthe case of any new regulatory restriction to be applied to access to OTC medicines.

GST

The complicated and irrational situation on GST on medicines was described above.In ASMI’s view, it isneither equitable nor rational to tax products which people use tomaintain their health but not to tax those (such as prescription medicines) used tocuring illness.


The GST was removed from medicine products–as ASMI has long advocated–there would be an immediate 10% cost reduction in a range of medicines whichpeople need and use regularly. While small, such a reduction could have a small,but significant effect on working families’ budgets. It would put downward pressure on prices at a time when the authorities should be doing everything possible to fightinflation.

The cost to revenue–which goes to the States and Territories–is estimated ataround $200m/yr. At a time when there are strong fiscal policy reasons to reducepublic outlays, such a revenue loss is more than reasonable.

ASMI recommends that the inquiry find that removing the GST on all medicinesentered on the ARTG would benefit working families and promote theGovernment’s preventative health agenda.

Conclusions and Recommendations

Medicines that can be sold in other than pharmacies exhibit the same characteristics–for the purposes of this inquiry–as other lines on sale in groceries orsupermarkets.

ASMI would like to see maximum access by the public to OTC medicines, consistentwith principles of public health and safety.

We recommend that this inquiry find that it is in the interests of consumers that theregulatory regime for OTC medicines to be the minimum consistent with public healthand safety.

ASMI also recommends that this inquiry find that costs to consumers can bereduced by removal of the GST on all therapeutic goods entered on the ARTG.


Attachment 1

About ASMI

ASMI (Australian Self Medication Industry) is the peak body representing companiesinvolved in the manufacture and distribution of consumer health care products in Australia.ASMI also represents related businesses including advertising, public relations, legal,statistical and regulatory consultancy companies and individuals.

Our purpose is to promote 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 alsogather the best and most current information from diverse sources in order to keep our membersinformed of the latest developments in the consumer health care products industry.

ASMI is a member of the World Self-Medication Industry (WSMI) and our President and ExecutiveDirector sit on the Board of that organisation. WSMI is a non-government organisation made up ofover 50 member associations around the world, with affiliations to the World Health Organisation.

ADVOCACY, REPRESENTATION and INFORMATION

Better health through responsible Self Care.

ASMI VISION

SELF CARE: THE FOUNDATION FOR A HEALTHY AUSTRALIA

nation where individuals and families choose to maintain good physical and mental health using arange of strategies including regular exercise, healthy eating and the appropriate use of self-medication to treat and prevent illness.There is growing evidence, including research sponsored by ASMI, to show that effective Self Carewithin a community can help to prevent disease, manage existing conditions and improve the qualityof life and general health of the population. As a result, the economic burden on government healthand welfare bodies can be considerably reduced.

ASMI believes that the benefits of Self Care can be realised through the formation of strongpartnerships between industry, government, consumers, health care providers and other stakeholdersas well as through scientific and economic research. We will continue to build our relationships andsupport the development of an evidence-based platform which will give Self Care a significant placein Australian health management.

ASMI

ASMI the voice of the consumer Self Care products industry, driving a credible and expandingevidence-based self-medication market to generate cost-effective health solutions and improvedpublic health outcomes.

ASMI MISSION

> Drivers of change through member contribution and industry interaction.

> Best practice in governance and service.

> Committed to representation by consumers.

> Consistent in policy and action.

> A learning organisation committed to competency development.

ASMI VALUES

ASMI Members

Ordinary Members

Allergan AustraliaAspen PharmacareBayer Healthcare Consumer CareBiological TherapiesBoehringer IngelheimC B Fleet Co (Australia)CatalentChurch & Dwight AustraliaCombe InternationalEgo PharmaceuticalsFlordisGaldermaGlaxoSmithKline Consumer HealthcareH W WoodsJohnson & Johnson PacificMentholatum AustralasiaNestle AustraliaNycomedNovartis Consumer Health AustralasiaProbiomicsProcter & Gamble AustraliaReckitt BenckiserRoche ProductsSandozSanofi-aventis Australia New ZealandSchering-PloughSmith & NephewStiefel LaboratoriesStirling PharmaceuticalsSymbion ConsumerWyeth Consumer Healthcare

Associate Members

ACNielsen AustraliaAgilent Technologies AustraliaAnthea Steans ConsultingArcher Emery & AssociatesAZPA InternationalBASF (Vic)Bronson & JacobsClare Martin & AssociatesClayton UtzContract Pharmaceutical Services of AustraliaCurtis Jones & Brown AdvertisingEngel, Hellyer & PartnersEuro RSGC LifeFreehillsH&TIMS Health AustraliaKendleLabmarkLipa PharmaceuticalsLove CommunicationsMinter EllisonNational PharmaciesOz Pharma Contracting & ConsultingPalin CommunicationsPathway InternationalRegulatory ConceptsRemediesScental PacificSingleton Ogilvy & MatherSynovate AztecSue Akeroyd & AssociatesTechnical Consultancy ServicesThe Sales FactoryThomson PlayfordURSA Communications

Australian Self Medication IndustrySuite 2202, Level 22, 141 Walker Street, North Sydney NSW 2060

PO Box 764, North Sydney NSW 2059Telephone: +61 2 9922 5111 Facsimile: +61 2 9959 3693

www.asmi.com.au

ASMI


Attachment 2

Self-care in Australia 1

Self-Care inAustraliaThe foundation fora healthy nationWhat is Self-Care?

Self-care is a personal choice in healthmaintenance; it is the extent to which anindividual, family or community engages inany activity with the intention of improvinghealth, preventing disease, managingconditions, and restoring health.

Encompassing a broad spectrum ofbehaviour, self-care includes all healthdecisions consumers make for themselvesand their families to maintain a good levelof physical and mental health. Theseinclude maintaining physical fitness andgood health to preventing disease ormanaging conditions, using self-medication to treat and prevent illness,

from tertiary health care.

Self-care may be used alone (treating amild headache), or may be used incollaboration with professional care(treating hypertension, see Figure 1). TheAustralian Self-Medication Industry (ASMI)believes that fundamental to the successof self-care is the formation of strongpartnerships between governments,industry, consumers, health care providersand other interested stakeholders.

The Rise of Self-Care

The consumer is a rising power inAustralia. Demanding greater information,choice, and responsibility, Australians areready to take control of and manage theirhealth. Increased media coverage, greateraccess to resources and increasededucation have all sparked a shift inattitude for many Australians. As a result,Australians are spending over $900millioni a year on herbal medicines,vitamins and supplements, while 500,000people in NSW alone (1.6 million Australia

health clubs. ii

However, the message is not reaching allAustralians, and more can still be done toraise the profile of self-care in thecommunity. The prevalence of certain highhealth risk factors is on the rise inAustralia. 44% of all Australians areinactive, while 62% of Australian maleswere classified as overweight in the 2004-05 National Health Survey, rising from58% in 2001 and 52% in 1995. Theproportion of females overweight or obeserose from 42% in 2001 to 45% in 2004-05.Over 77% of adults have at least one ormore long term medical condition. iii

These risk factors contribute to a myriad ofresulting conditions; some of thoseidentified by the National Health PriorityList have been highlighted alongside theirself-care solution in Appendix 1.

Did you know?Total spending on health was$87.3 billion in 2004/2005Up $8.2 billion from theprevious yearGovernment picked up 68.2%or about $59.4 billion of thatcost iv


There is growing evidence to support thenotion that promoting self-care leads to anumber of benefits for the community andgovernment through:

prevention of disease andincreased productive life of theindividual;management and control ofexisting conditions;improved general health andquality of life; andreduced resource burden ongovernment health and welfareservices.

Self-Care in the AustralianContext

Currently Australia does not have acomprehensive health policy in place. Thatis, a policy that examines health beyondsimply the realm of health care (treatingillness) but also all the factors contributingto the overall health of the nation:

Family Income/WealthEducationSocial supportWorking conditionsEnvironmentBiology/geneticsHealth servicesChildhood developmentPersonal health activities and life skills

A comprehensive health policy recognisesthe effects of these health determinants on

health outcomes and allocates resourcesappropriately. The Ottawa Charter onhealth promotion (WHO, 1986) suggestedthat health policy should encompass allthe legislative, fiscal, taxation, andorganisational measures required incoordinating action that produce goodhealth.

While there are several health promotioninitiatives in operation, a more directedand organised approach is required.Official recognition of self-care as afundamental means of nurturing the healthof all Australians is essential.

The Australian CommonwealthGovernment has identified Aboriginal andTorres Strait Islander populations as onesof major health concern.

Indigenous peoples are generally morelikely to develop conditions contained inthe Health Priority Areas than non-indigenous populations, they are forexample, 2.7 times more likely to developcardiovascular disease and 8.3 timesmore likely to develop endocrine diseasessuch as diabetes. v

The prevalence of certain risk factors suchas smoking and obesity is also higher inindigenous populations, areas anintegrated approach to self-care cansignificantly address. ASMI believes self-care can play a vital role in the effectivedelivery of important governmentstrategies such as the Health for LifeProgramme to these populations.


There is a great deal of research frommany parts of the world suggesting thatself-care can play a vital part in building asustainable, patient-orientated health caresystem. Such a system would involve:

greater State and Federal cooperationin promoting self-care initiatives andmaking sure they are taken up;nationwide awareness campaignsinclusive of all Australians; andsupport and information provided tohealth care collaborators such asdoctors, pharmacists and nurses toassist them in dispensing appropriateself-care advice.

Supporting Self-Care

Providing an environment conducive toself- lity. Itinvolves equipping consumers with thechoices, skills and tools necessary tomake their own health care decisionsappropriately, confidently and effectively.In addition, industry and health providersrequire the tools, training and supportnecessary to assist all Australiansappropriately.

Self-care needs to be presented to thepopulation from many angles and must beinclusive of all demographics. Effectivemethods of promoting self-care include:

Responsible, effective and accessibleinformation and advice available in avariety of languagesTraining the individual and communityfrom an early age in the importance ofself-care through:

o Physical Educationo First Aido Safe use of medicineso Personal hygieneo Treating minor ailmentso Preventing illness

Training of practitioners in providingself-care supportEncouraging a change of mindsetwithin health care professionals to onesupportive of self-care througheducationCondition management skills forchronic sufferers with the assistance ofthe relevant condition associations andgroupsIndividual care plans, andprofessionals to assist in theirimplementation and maintenanceEducating consumers on the roles ofhealth care professionals anddispelling myths and misconceptionsCollaboration with cultural andreligious groups and associationsLifestyle advice through training,campaigns, and mediaEncouragement of a collaborativehealth care environmentFacilitating the switch of appropriateprescription-only medicines to over-the-counterEnsuring self-care products, such asOTC and complementary medicinesprovide adequate consumerinformationASMI believes firmly that a consumer

packaging and information thatensures the therapeutic good can besafely and effectively usedProvisions for a subsidised annual

-to identify Australians at risk and placethem on a preventative self-care planEmpowering pharmacists and nurseswith additional responsibility. (For

Australians Living Dangerously

The report, Living DangerouslyAustralians with multiple risk factors forcardiovascular disease (AIHW, Feb2005) says that;

9/10 Australians have at least 1 riskfactor of cardiovascular disease,most have at least 2Poor activity and diet are the mostprevalentPeople of most disadvantagedsocioeconomic groups are morelikely to have 3 or more risk factors.

Conclusion: There is great scope forthe improvement of the health of

vi


example, allowing pharmacists ornurses limited prescribing and issuingof medical certificates valid for 1 3days)Incentives through private healthinsurance to encourage engagementof nutritionists, naturopaths and othercomplementary healthcareprofessionals to help developstrategies for longer term holistichealth maintenance.

A cornerstone of effective self-carepractice is ensuring the individual feelsinvolved and in control in the managementof his or her own health. Doctors,complementary health care professionals,pharmacists and nurses, Health CareCollaborators, should be encouraged tocommunicate with those seeking healthcare and with each other in providing thehealth service. Australians should beactively engaged and consulted abouttheir options, and only with their informedapproval should treatment decisions bemade collectively.

situation is unique and acknowledging that

everyone holds a high degree ofresponsibility for their own health, anintegrated health approach involving self-

health status in their own context.This involves the doctor working with thepatient to maintain health and prevent ill

and environmental context. Integratedhealth is an acknowledgement that notone therapeutic practice can hold acomplete monopoly on the diagnosis andtreatment of all conditions, but rather thatpartnerships need to be formed to ensureall Australians receive an optimal standardof care.

A GP may, for example, prescribe acholesterol-lowering medication for apatient and in addition, under anintegrated health approach, would identifythe underlying factors contributing to the

include poor food choices, obesity, stress,or inactivity. An integrated approach couldsee the doctor recommend consultationwith complementary practitioners, adviceon complementary and OTC medicines orsuggest lifestyle changes and other self-care measures.

This sort of cooperation is already takingplace. The Prince of Wales Foundation isa body operating in the United Kingdomwith the primary directive to forgepartnerships between conventional andcomplementary bodies to encourage anintegrated approach to health. Moreinformation about integrated health and

their website. (http://www.fihealth.org.uk)

Combination TherapyComplementary and prescriptionmedicines can be used in anintegrated manner to treat commonailments.A Medical Journal of AustraliaArticle, Lipid Modifying Drugs (21March 2005) reports that the use ofa statin in combination with fish oilis a relatively safe and effectiveoption in treating highconcentrations of triglyceridesand/or LDL-C cholesterol. ix

Self-Care Fact CardsThe Pharmaceutical Society ofAustralia produced a series of 81self-care fact cards educating theconsumer on common conditionsand what measures can be takento manage them;

97% of consumers weresatisfied with the cards

informative and helpful, and

to go to a chemistthan to a doctor. The FactCards provide reassuringinformation and you can go tothe doctor if the informationon the Cards suggests this

viii


Switch and the Consumer

prescription medicines proven to be safeand effective to over-the-counter status,improving accessibility to the consumer. Inthe United States, there are over 700 OTCproducts on the market using ingredientsor dosages only available by prescriptionless than thirty years ago. x Uptake ofthese switched products can be very

the United States generated US$2.36billion in annual sales and accounted for55-60% of market growth. xi

As pharmaceutical products come offpatent, and generic preparations enter themarket, OTC switching of products is likely

contain revenue loss. As a result of fallingprices in generic prescription categories,pharmacy will probably begin to placegreater attention on switched OTCpreparations.

The idea that pharmaceuticals are only

decades of distribution under prescriptionstatus is changing. ASMI believes thatdose should be one of the primary factorswhen considering a switch. There aremany applications such as statins in whicha lower dose preparation is appropriate forOTC distribution while higher dosagepreparations more appropriately remainprescription-only products.

In ensuring that safe and effective self-care products are available to Australiansat reasonable cost, ASMI is committed toensuring OTC and complementaryproducts are used safely and effectively asthey begin to play an increasing role in

rall health care strategy.

Benefits to Australians

The goal of an integrated self-careapproach to health is ultimately to improvethe lives of all Australians under a moresustainable and effective health system.Direct benefits to consumers include:

Improved overall sense of health and-

expectancyPrevention of ill healthGreater control over health decisionsand as a result, greater confidence inthe health systemLower private health insurancepremiums due to reduced claimsAn improved health service asgovernments are able to divert fundssaved from a reduction in demand onhealth care services to R&D, healthsupport activity or reduced taxesImproved condition management, fromminor ailments to chronic conditionsReduced time off work or out of roledue to medical consultations

Statins A Case for SwitchAn estimated 14.8 million peopleworldwide use statins, a class ofcholesterol-lowering drug aimed atreducing the risk of CHD accreditedwith saving over 17,000 livesannually. xii

In the past year the UK has allowedOTC status for a low dose statin,while the FDA and TGA areinvestigating the potential switch ofcertain substances in this class.

Coupled with strong consumereducation and support, a switch ofthe substance to OTC status wouldprovide a raft of benefits toAustralians including ease ofaccess and improved healthoutcomes.


Benefits to Health Care Services

Self-care can benefit the health care

improve the effectiveness and efficiency ofthe services they provide. The directbenefits to health care providers wouldinclude:

Reduced demand on overstretchedgovernment resourcesFewer Medicare claims through areduction in unnecessary GP visitsFewer admissions to hospital and outpatient clinicsFewer accident and emergency visits

Savings in all these areas could allowAustralia to invest more in the researchand development of new medicaltechnologies and techniques benefiting allAustralians while supporting local industry.

Types of Self-Care andOpportunity for Support

Minor ailments and injuries place a heavy

Many visits to the doctor are for minorconditions that could in many cases betreated just as effectively through self-care. Self-medication in consultation with

other health care professionals such aspharmacists would be appropriate in manycases. In any two-week period, 14% ofAustralians xiv will have one or more daysoff work due to illness, coming at a cost tothe individual, employers and thegovernment. Under a self-care paradigm,consumers would be more confident intreating and preventing many minorailments themselves.

Australian consumers are ready for self-care. Research conducted by ASMI hasshown that 90% of Australians would liketo know as much as possible about anyillness or condition they may have in orderto improve their own self-care. 86% areconfident in treating minor ailmentsthemselves while 84% of individuals dowhat they can to self-care before visiting adoctor.

In treating minor ailments, 78% ofAustralians took self-care measures tomanage their most recent condition.

Consumers are also responsible inpurchasing OTC medicines. 94% ofconsumers describe themselves as verycautious and careful regarding themedications they take. 77% state theyalways read the label the first time theypurchase an OTC product, primarilylooking for dosage, any potential sideeffects, and ingredient information. xv

Australian Success StoryThe DHA report, Returns oninvestment in public health found thatin regards to smoking prevention,publicly funded programs; xiii

Have saved government $344millionOr $2 for every $1 spentMale smokers down from 45% to27% and females from 30% to23%

Where to now?OsteoporosisCardiovascular diseaseDiabetes


86% of GP consultations in Australia resultin a prescription being written; xvi it isthought that many of these could betreated with an over-the-counter orcomplementary medicine. Diverting someof the cost of medication to the consumercould result in significant savings in PBSexpenditure (currently at $6,001.2m) xvii.The consumer would in turn save fromreduced visits to the doctor and theassociated costs involved such astransport and time off work.

An NDMAC study found that byswitching non-sedating antihistaminesalone to OTC status, the Canadiangovernment would save $CD11.6mand the consumer, $CD4.4m on doctorvisits. xviii

Research conducted by the North-Western University (US) in 2004 foundthat over-the-counter medicationsused in treating common UpperRespiratory Infections (URI) potentiallysave the US economy $US4.75 billionper annum in demand on healthresources and lost productivity. xix

In the last National Health Survey, 87% ofthe Australian population was reported ashaving a long-term medical condition. xx

Chronic and long-term conditions pose amajor obstacle to better Australian health:

Chronic conditions are estimated toform 80% of the total burden ofdisease, mental illness and injury. xxi

70% of GP consultations involved thetreatment of a chronic condition ofwhich the most common problem wasnon-gestational hypertension (9.2 per100 encounters). xxii

30.5 potentially preventablehospitalisations per 1000 population.xxiii Chronic conditions account for themajority of bed days.As the Australian population ages, theprevalence of long term conditions willincrease, further straining alreadystretched resources.

Self-care measures, such as life-styleadjustments and self-medication, can bothprevent and control chronic conditions. Byidentifying risk factors early, an individualcan self-care by taking preventativeactions and avoiding or delay the onset ofa chronic condition. For people sufferingfrom chronic conditions, self-care can beused to control the symptoms and managecomplications.

Australians are interested in theprevention and management of illness,and are willing to look beyond the realm ofconventional medicine for alternatives. Inrecent consumer research, 74% ofAustralians reported the use of at leastone complementary medicine in theprevious 12 months. xxiv A South Australianstudy found that Australians spent $2.3bnon alternative therapies in 2000,representing a 62% increase since1993.xxv

Information and ongoing support isrequired to provide the consumer with anunderstanding of their condition and theconfidence to manage any symptoms orcomplications, and to slow downdeterioration. Not only will this maintain agreater quality of life for the individual, butalso it would reduce pressure on high costservices such as hospitals and aged care

independent or productive lifetime.


When a patient is discharged fromhospital, self-care plays a primary role inensuring rehabilitation. To preventreadmission or further deterioration, it isvital to ensure that patients understandtheir conditions and know where andwhom to ask all the questions they maynot have thought of when originallydischarged.

For example, an elderly man required torecover for long periods in bed followingtreatment should be provided with simpleexercises to maintain mobility in the upperbody. He should also be provided withadvice on medication to take to reduce therisk of thrombosis. This would help ensurethe patient is able to resume his regularlife post recovery and prevent furtherdeterioration to a more dependent status.

Health care providers can supplyimportant self-care advice and guidancethrough a rehabilitation program to ensurethat normal function can be restored whilemaintaining a favourable quality of life.

Individual Measures to EnsureAdequate Self-Care

As self-care is an individual choice (seeFigure 4), and since not everyone is inpossession of the same skills or abilities, itis important to ensure that people haveadequate access to the appropriate healthcare facilities and advice. MeasuresAustralians can take for self-care include:

Taking an interest in their own healthand that of their familyFollowing a healthy lifestyleSeeking out relevant healthinformation when necessaryCaring for minor illnessSelf-managing long term conditionswith appropriate and relevant healthcare intervention and monitoring

Collaborating with health careprofessionals such as doctors, andpharmacists with regards to the healthof themselves and their family.

Self-care requires the individual to takegreater control over his or her own health.Pre-requisite personal attributes to theeffective and safe practice of self-careinclude:

Adequate literacy and cognitive abilityExisting knowledgeConfidenceA sense of efficacyValues and ethicsPersonal and community responsibilityA desire to self-care.

While governments and other bodies canplay a vital role in providing the individualwith the required skill set to self-care, itmust be remembered that self-care is the

Challenges

While the aim of self-care is to promoteoverall well-being and health in Australia,as with any health measure there are risksinvolved, including:

Ensuring the individual meets theminimum requirements to be able toproperly self-care


Availability of resources to support theindividual in making correct self-caredecisionsEqual opportunity of access to self-careAppropriateness of self-care measureschosen by the individualEnsuring open and effectivecollaboration between health careprofessionals and consumers

Governments and health careprofessionals can play a key role inensuring Australians are equipped with theknowledge and skills required to safelyand effectively self-care.

Supporting Self-Care

While not officially part of the Australian

are a number of self-care related initiativesin place by both federal and stategovernments in addition to other relevantbodies. These include:

The Active Australia program is thecurrent federal umbrella healthpromotion strategy. It includes websiteand school curriculum requirements(www.healthyactive.gov.au).QUIT smoking campaigns and othercondition/lifestyle specific campaigns(www.quit.org.au).Initiatives by GP groups to becomemore active in lifestyle intervention andpromoting disease prevention.Pharmacy initiatives to promote self-care, such as self-care fact cards(www.psa.org.au).

Government can play a vital role inensuring a national environmentconducive to consumers adopting self-care.

funded and controlled health programscurrently in operation to create a more

collaborative approach, as well asachieving greater efficiency and costsavings.Provide consistent and persistentpublic campaigns through mainstreammedia. The QUIT campaign is anexcellent example.Provision in school curricula of materialand activities to instil solid self-carevalues from an early age: physicaleducation, medication safety, andgeneral knowledge about theAustralian health care system.Ensure that education continues inadulthood via public awarenesscampaigns and community healthservices.Establishment and maintenance ofcondition management groups andeducation resources for persons withchronic illnesses.Provision of tools and training to healthcare collaborators so that adequateself-care advice and support can beprovided to the individual.

Provide incentives for industry in theself-care field, including implementingdata protection periods to fosterinnovation in complementary and OTCmedicines.Develop the health IT infrastructureand applications (such as theelectronic health record) to enhancefurther the ability of doctors andpharmacists to provide self-caresupport.

The Government recognises thateffective preventive action hasthe potential to make a greatcontribution to improving healthoutcomes and quality of life,minimising unnecessary demandfor health care services, andensuring these services aredirected at those who really needthem.

The Hon Christopher Pyne MP,Parliamentary Secretary to the Ministerfor Health & Ageing speaking at the2005 ASMI Conference.


Encourage community participation inthe formation of self-care strategies toensure adoption.

Advocacy groups play a vital role inAustralian health. Generally representing aparticular condition or range of relatedconditions, they form a powerful interfacebetween the health user, the healthsystem and its decision makers.

In addition to serving as a source ofcredible education for consumers, mostgroups strive to raise public andgovernment awareness with regards totheir condition and make the case fordirecting additional resources or educationto assist people with a certain condition orto prevent the wider population fromdeveloping a condition.

Some important Australian advocacygroups include:

Arthritis AustraliaAsthma Foundations of AustraliaAustralian Injury PreventionNetworkbeyondblueCancer Council AustraliaDiabetes AustraliaMental Health Council of AustraliaNational Asthma Council AustraliaNational Stroke FoundationOsteoporosis AustraliaThe Heart Foundation

Self-Care Internationally

Several nations have already begun themove towards a broad approach to healthand have built provisions for self-care andhealth promotion into their health policy.

In 1994 the Canadian governmentofficially endorsed the populationhealth approach. This approachexamines the health of populations orcommunities in achieving healthoutcomes. By directing investment at

root causes and promoting self-care, itaims to improve the health status of apopulation and reduce the need forheavy spending at the health care endof the spectrum.Following a breakthrough in 2000 inthe NHS document The NHS Plan,self-care has received growingexposure and support in the UK. Inlate 2004 the Department of Healthpublished the breakthroughcommunication entitled Self Care AReal Choice, providing an introductionto the developing policy of self caresupport while providing a possible planfor the future. Committing to increasingthe range of medicines available over-the-counter, the government hasformulated a number of strategies

outcomes (see Image 1).

Health Wise Consumers

In a project beginning in 1996,Healthwise, a US based non-profitorganisation, implemented theHealthwise Communities Project.

Distributed to 154,000 families andsupported by a telephone adviceservice, the Healthwise Handbookcontained 180 common ailments andinformation on how to self-care forthem and when to consult a healthprofessional. Support was providedto health professionals on workingwith a better-informed consumer.

A report into the success of theproject found that the handbooksaved an estimated US$34.5m infewer hospital visits during the 30-month campaign. This represented asaving of US$11 for every US$1spent on the project.

Buoyed by the success of the projectevery family in British Columbia,Canada, has been provided with ahandbook. xxvi


Forging Solid Partnerships

ASMI believes that the success of self-care rests on the creation of strongpartnerships amongst all the involvedstakeholders. They include:

GovernmentConsumersIndustryEducational InstitutionsHealthProfessionals/CollaboratorsHealth InsurersMedia.

Successful and meaningful cooperationand consultation between these groups isessential in ensuring that the commongoal of improved and sustainable healthoutcomes for all Australians is achieved.

Self-Care: for All Australians

under the challenges of technologicaladvances matched by rising consumerexpectations, demand for greater choice,and an ageing population, Australia mustexamine its health situation and providehealth solutions that will benefit the wholecommunity. In order to build a moresustainable and effective health system for

Australia, a comprehensive health policy isessential. By embracing the self-caremodel, Australians will be personallyempowered to improve their own healthoutcomes and ensure Australia retains itsplace as a global leader in consumerhealth.

ASMI Research

Parliamentary Secretary for Health,Christopher Pyne, announced that theAustralian Federal Government willprovide $65,000 in funding to partner withASMI in a research project to evaluate theevidence for selected complementary andOTC medicines. He told conferencedelegates:

that self-medication is an integral part ofan Australian self-care system. In orderto adequately respond to the needs ofconsumers, the Government dependsgreatly on the support of your industry tofacilitate and encourage responsible andinformed self-medication

About ASMI

The Australian Self-Medication Industry isthe peak industry body for the Australianself-care industry representing consumerhealthcare products including over-the-counter medicines and complementary

better health through responsible self-care. This means ensuring that safe andeffective self-care products are readilyavailable to all Australians at a reasonablecost. ASMI works to encourageresponsible use by consumers and anincreasing role for cost-effective self-medication products as part of the broadnational health strategy.www.asmi.com.au

For more information about Self-Care visit usat http://www.asmi.com.au/Self-Care.htm.


Appendix 1: National Health Priority Areas

AsthmaBackground:

Effects 2 million Australians (10%), 1 in 4 primaryschool children2004-05 ABS 3.1% of suffers had one or more daysout of work or study.Major cause of school absences, child emergencyand hospital admission60,000 Australians admitted annuallyCost to employers for asthma-related absences inexcess of $110 million

COST: $0.7 billion (1.7% of total allocated healthexpenditure) vii

The Role of Self-CareExerciseHealth Professional adviceSupport & educational groupsInhalers (Preventers and relievers)Nicotine Replacement Therapies (Forsmokers)Non-sedating antihistamines

Arthritis and MusculoskeletalconditionsBackground:

2004-05 Health Survey estimates 15% of Australianssuffer from arthritis2004-05 ABS 40% of Australians living with Arthritistreat their condition with vitamins, minerals or herbaltreatments. 37% used pharmaceutical medications.Estimated that 50% of Australian women aged 65 andover may have osteoporosis and not know it.The Australian Institute of Health and Welfareestimates that almost 75,000 years of healthy life arelost to arthritis annually.

Cost to government: $4.6 billion (9.2% of totalallocated health expenditure) vii

The Role of Self-CareDietExerciseHealth Professional adviceSupport & educational groupsAspirinBorage Oil (Borago officinalis) /gammalinolenic acidCalcium / Vitamin DChondroitinDevils Claw(Harpgophytumuprocumbens)DiclofenacEvening Primrose Oil / gammalinolenic acidFish OilGlucosamineIbuprofenNaproxenNettle (Urtica dioica)ParacetamolWillow bark (Salix spp)


Cardiovascular HealthBackground:

Cardiovascular disease causes more deaths than anyother disease, accounting for 50,797 deaths (40% ofall deaths) in Australia in 1998.Coronary artery disease (mainly heart attacks) is theleading singular cardiovascular cause of death,accounting for 27,825 deaths (22% of all deaths) inAustralia in 1998.Stroke is the major cause of serious long-termdisability in adults.Most costly condition for the Australian health system.It was responsible for 12% ($3.9 billion) of totalrecurrent health expenditure in 1993-94.


The Role of Self-CareDietExerciseHealth Professional adviceSupport & educational groupsAspirinCalciumCo-Enzyme Q10Folic AcidGarlicGinkgo BilobaGlobe Artichoke Leaf (Cynarascolymus)Nicotine Replacement Therapies (ForsmokersOmega-3 / Fish oilsOrlistat / Obesity medicationsPsyllium / IspaghulaVitamins B, C & E - Multivitamins

CancerBackground:

Cancer currently accounts for 30.2% of male deathsand 25.2% of female deaths each year.Each year about 345,000 people are diagnosed withcancer. Approximately 270,000 of these are non-melanocytic skin cancers (the less threatening form ofskin cancer).The most commonly detected cancers are prostatecancer in males, breast cancer in females.In 2006 there were 39,200 deaths in Australia fromcancer, and the most common cancers causing deathwere lung cancer in males and breast cancer infemales.At the prevailing cancer incidence rates, it may be

expected that one in three men and one in fourwomen could be directly affected by cancer by the ageof 75.


The Role of Self-CareDietExerciseHealth Professional adviceSupport & educational groupsNicotine Replacement Therapies (ForsmokersSaw Palmetto


DiabetesBackground:

An estimated 940,000 Australians aged 25 years andover have diabetes; around half of these people arecurrently undiagnosed.The number of adults with diabetes has trebled since1981Diabetes occurs in disproportionately high numbersin populations includingo Older Australianso Aboriginal and Torres Strait Islanderso European born men and womeno Asian born women


The Role of Self-CareDietExerciseHealth Professional adviceSupport & educational groupsHydroxyethylrutosides (Chronic venousinsufficiency)Orlistat / Obesity medicationsVine Leaf (vitis viniferae) (Chronicvenous insufficiency)

Injury PreventionBackground:

Injuries result in an estimated 8,000 or 6% of deathseach year in AustraliaApproximately 400,000 hospital admissions annuallyare due to injuriesInjuries are the main cause of death for people underthe age of 45

COST: $4.0 billion (8% of total allocated healthexpenditure) vii

The Role of Self-CareDietEducationExerciseHealth Professional adviceSupport & educational groupsAspirinBorage Oil (Borago officinalis) / gammalinolenic acidCalcium / Vitamin DChondroitinDevils Claw(Harpgophytumuprocumbens)DiclofenacEvening Primrose Oil / gamma linolenicacidFish OilGlucosamineIbuprofenNaproxenNettle (Urtica dioica)ParacetamolWillow bark (Salix spp)


Mental HealthBackground:

About 1 in 5 Australian adults and 1 in 7 children willexperience mental illness in any given year.The most common illnesses are anxiety, depressionand alcohol dependence.In any one month, approximately 58,000 adults usepsychiatric services due to psychotic illness.Schizophrenia accounts for around 40,000 of these.Of the approximately 500,000 children affected bymental illness, 200,000 have aggressive disorders,93,000 with anxiety or depression, and 93,000 withattention disorders.


The Role of Self-CareDietExerciseHealth Professional adviceSupport & educational groupsFolateGinkgo bilobaKava (Piper methysticum)St Johns Wort (Hypericum perforatum)Valerian (Valeriana officinalis)


Endnotes

i Industry Estimate, 2004ii IBISWorld, Who are the real winners in

,(IBISWorld Press Releases, 2004),http://www.ibisworld.com.au/static/PressReleases.asp?ContentItemID=184iii Australian Bureau of Statistics (ABS),National Health Survey 2004-05. (ABS,2006)iv Australian Institute of Health and Welfare(AIHW), Health Expenditure Australia2004-05. (AIHM, September 2006)v National Health Priority Action Council(NHPAC), Summary Report of theAboriginal and Torres Strait IslanderHealth Workshop, (NHPAC, May 2003)vi Australian Institute of Health and Welfare(AIHW), Living Dangerously Australianswith multiple risk factors for cardiovasculardisease (AIHW, February 2005)vii Australian Institute of Health andWelfare (AIHW), Health systemexpenditure on disease and injury inAustralia, 2000-01 2nd Edition. (AIHW,April 2005)viii Pharmaceutical Society of Australia(PSA), Pharmacy Self-Care ResearchReport. (PSA, 2004)ix Leon A Simons and David R Sullivan, Lipid ModifyingDrugs, 2005; 182 (6):286-289

x Consumer Healthcare ProductsAssociation (CHPA), OTC Facts andFigures, (CHPA 2005), http://www.chpa-info.org/web/press_room/statistics/otc_facts_figures.aspxxi Alain Bonta, How to get your brand tothe consumer, presentation to theAssociation of the European Self-Medication Industry (AESGP) May 2000.xii Pharmaceutical Field, Statins go OTC inBritain. (Pharmaceutical Field 2005)http://www.pharmafield.co.uk/asp/article.asp?id=114&source=1xiii Department of Health and Ageing(DHA), Returns on Investment in PublicHealth : An epidemiological and economicanalysis. (prepared for the DHA,September 2004)xiv Australian Bureau of Statistics (ABS),National Health Survey 2001. (ABS, 2002)xv Dr David N Darby,Perspective on Health and Medication with

an emphasis on self-care and self-medication. (Australian Self-MedicationIndustry, 1996)xvi Australian Institute of Health andWelfare, University of Sydney, GeneralPractice Activity in Australia 2003-04.(AIHW, December 2004)xvii Pharmaceutical Benefits PricingAuthority, Annual Report for the yearended 30 June 2005. (DHA, Dec 2005)xviii Nonprescription Drug Manufacturers ofCanada, The Economics of Self-Medication, (NDMAC, 30 June 1995)http://www.ndmac.ca/xix NorthWestern University MediaRelations, Over-the-counter Drugs CouldSave $4.75 Billion Annually. MediaRelease. (NorthWestern University, 9November 2004)xx Australian Bureau of Statistics (ABS),National Health Survey 2001. (ABS, 2002)xxi Australian Institute of Health andWelfare, Health system expenditure onchronic diseases. (AIHW, 23 June 2005)xxii Australian Institute of Health andWelfare, University of Sydney, GeneralPractice Activity in Australia 2003-04.(AIHW, December 2004)xxiii Australian Institute of Health andWelfare, Australian Hospital Statistics2003-04. (AIHW, 27 May 2005)xxiv Cardinal Health, Vitamin, Mineral,Herbal and Nutritional Supplements(Cardinal Health, 2004)xxv Ian D Coulter and Evan M Willis, Therise and rise of complementary andalternate medicine: a sociological perspective.

MJA 2004; 180 (11): 587-589 (Medical Journal of Australia,2004)xxvi Healthwise, Partners health initiativeestimates $34.5 million savings inunnecessary health care costs.(Healthwise, 2004)

Document Revised July 2007


Australian Self-Medication Industry Inc

ABN 55 082 798 952Level 22, 141 Walker Street, North Sydney NSW 2060

PO Box 764, North Sydney NSW 2059Ph +61 2 9922 5111 Fax +61 2 9959 3693

[email protected] www.asmi.com.au

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