THE AUSTRALIAN COMPLEMENTARY MEDICINES INDUSTRY – A PRELIMINARY STUDY INTRODUCTION Complementary medicines (CMs) have become an important sector of Australia’s healthcare system. A survey commissioned by Cardinal Health in 2004 found that 74% of the population had taken one or more vitamin, mineral, herbal or nutritional supplements in the previous 12 months1, and usage rates are expected to rise. DEFINITIONS INDUSTRY DEFINITION There is no universally accepted definition of the term ‘complementary medicines’. In an Australian context, it includes ‘herbal medicines, vitamin and mineral supplements, other nutritional supplements, traditional medicines such as Ayurvedic medicines and traditional Chinese medicines (TCM), homoeopathic medicines, and aromatherapy oils (where they make therapeutic claims)’.2 See Table 1. Table 1 Classes of complementary medicines Herbal medicines

Traditional medicines

Vitamins and minerals

Nutritional supplements

Homeopathic medicines

Aromatherapy products

Ayurvedic medicines

Traditional Chinese medicines

Other traditional medicines

Source: Complementary Medicines in the Australian Health System (2003), p. 432. For further discussion of the term from an Australian industry perspective, see Attachment A. REGULATORY DEFINITION Section 52F of the Therapeutic Goods Act 1989 defines ‘complementary medicines’ as ‘therapeutic goods consisting wholly or principally of one or more designated active ingredients, each of which has a clearly established identity and (a) a traditional use or (b) any other use prescribed in the regulations’. Schedule 14 of the Therapeutic Goods Regulations 1990 (the Regulations) designates the types of active ingredients that may be used in such medicines (see Attachment B). According to the Regulations, a ‘traditional use’ must be one that: • is well documented, or otherwise established, according to the accumulated experience

of many traditional healthcare practitioners over an extended period • accords with well-established procedures of preparation, application and dosage. Medicines not meeting the definition cannot be regulated as CMs. CMs may be included on the Australian Register of Therapeutic Goods (ARTG) as Listed or Registered medicines. Most are Listed (low risk) medicines. Registered (higher risk) CMs may be non-prescription, over-the-counter (OTC) medicines or medicines available only on prescription from a medical practitioner or other authorised prescriber registered under a law of a State or Territory.

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MARKET CHARACTERISTICS MARKET SIZE Reliable, objective statistics on the size of Australia’s CM market are hard to find because, to date, a comprehensive survey has not been carried out. No single representative body is responsible for collecting industry data, and the Australian Bureau of Statistics does not define the CM market separately. Furthermore, an estimated 60% of CM companies (i.e. importers and manufacturers) are privately owned, which means they are not obliged to provide public information on their sales.3 The Complementary Healthcare Council (CHC), however, notes that the industry consists of ‘mainly small and medium enterprises, with only a small number of players fitting the medium category’.4 A recent Australian National Audit Office (ANAO) report notes that a total of 143 OTC and/or CM manufacturers were registered with the Therapeutic Goods Administration (TGA) in December 2003.5 Of these, an undetermined number manufactured both OTCs and CMs.6 DOMESTIC AND EXPORT MARKETS Domestic markets Retail sales Industry groups and manufacturers put annual retail sales for the industry at $800 million to $1 billion (see Table 2). The figure may be equal to or even surpass pre-Pan sales.7, 8 This estimate equates to 10–13% of the combined sales of prescription and OTC medicines in Australia.9 In 2002, a University of Adelaide study stated that national expenditure for CMs was $1671 million10, but industry sources are of the view that, because this study extrapolated national figures from a survey of 3000 South Australians, it most likely inflates the total expenditure.11 Table 2 Estimates of retail sales of complementary medicines Source ASMIa DSAAb Symbion

Consumer CHC Sphere

Healthcare Blackmores

Value $800m to $1 billion

$900m $900m $900m $950m (assuming 500% mark-up of ex-factory price)

$950m

Date 2005 2004 2005 2005 2005 2004 a Australian Self Medication Industry b Direct Selling Association of Australia Sources: • Australian Self-Medication Industry (ASMI) website

www.asmi.com.au/Complementary%Medicine.htm (accessed October 2005) • Direct Selling Association of Australia (DSAA) communication, 25 August 2005 • Symbion communication, 29 June 2005 • CHC communication, 13 September 2005 • Sphere Healthcare communication, 4 August 2005 • Blackmores communication, 20 September 2005.

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Growth For the year to April 2005, CM sales are estimated to have increased by about 18%, based on dollar value sales at the retail level.12 Market share & industry concentration In contrast to pharmaceuticals, which is dominated by 12-20 large companies, with the top 20 accounting for 87 percent of PBS sales13, Australia’s CM industry is more concentrated, with a handful of large companies dominating product manufacture and supply. The remainder of the industry is comprised of a large number of very small companies: • three companies – Lipa, Sphere and Cardinal – account for 70–80% of CM contract

manufacturing14; and • about 42% of retail market share is accounted for by Blackmores (20% – based on

pharmacy and grocery sales), Symbion Consumer (22% – based on pharmacy and grocery sales) 15.

Also, in contrast to big pharma, the direct-to-consumer sector accounts for approximately 25% of all sales.16 Market segments CMs are distributed to customers through grocery stores (including supermarkets), pharmacies, health food stores, DTC sales and practitioner sales. Estimates of the relative sales volume served through these channels are shown in Table 3. Table 3 CM distribution channels Source CHC RIRDCa ASMI

Distribution channel and percentage

Pharmacies (36%) Health food (27%) Grocery (25%) DTC (7%)* Other (5%) * Based on data supplied to CHC by DSAA

Pharmacies (30%) Health food (20%) Grocery (15%) Direct sales (3%) Direct mail (9%) CM practitioners (2%) Multi-level marketing (21%)

Pharmacies (40%) Health food (20%) Grocery (20%) DTC (7%) CM practitioners (10%) Other (3%)

Date 2000 2000 2005 a Rural Industries Research & Development Corporation Sources: • CHC, quoted in A billion dollar industry’s struggle to find itself, Australian Journal of Pharmacy, vol.

81, December 2000, p. 172 • New Pharmaceutical, Nutraceutical & Industrial Products: The Potential for Australian Agriculture.

Rural Industries Research & Development Corporation (RIRDC) Publication No 00/173, November 2000, p. 76

• Australian Self-Medication Industry (ASMI) website www.asmi.com.au/Complementary%Medicine.htm (accessed September 2005).

The table, however, fails to capture two important trends: • a shift from health food stores to supermarkets and pharmacies17 • an estimated 400% relative increase in DTC sales since 2000. The DSAA reports that

member sales (i.e. DTC sales) for 2004 represented an estimated 25% ($231 million) of the total market ($900 million).18

Industry advice is that decisions as to how and where CMs are sold are influenced by: • the desire to leverage the influence network of healthcare specialists • consumer safety legislation (e.g. practitioner-only channels) • the need to minimise distribution costs (e.g. wholesale vs. mail-order channels) • consumer preferences (e.g. managed care vs. personal wellness management)

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• the use of the Internet by consumers (e.g. e-commerce channels) Sponsors and retail supply The role of the sponsor distinguishes CM and pharmaceutical supply chains from traditional supply chains. According to the Therapeutic Goods Act 1989, every listed or registered drug must have a sponsor. Section 3 of the Act defines a sponsor as:

(a) a person who exports, or arranges the exportation of, the goods from Australia; or (b) a person who imports, or arranges the importation of, the goods into Australia; or (c) a person who, in Australia, manufactures the goods, or arranges for another person

to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who: (d) exports, imports or manufactures the goods; or (e) arranges the exportation, importation or manufacture of the goods; on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

Note that sponsors may be manufacturers or they may contract out their manufacturing locally or overseas. Top-selling CM product segments A 2004 consumer survey (involving 813 respondents) identified calcium as the top-selling mineral, vitamin C as the top-selling vitamin, garlic as the top-selling herbal supplement and fish oil as the top-selling nutritional supplement.19 Top-selling brand Berocca ($20 million) is the biggest single brand, with the closest rivals at $6 million in sales.20 Export markets Export sales Total industry export estimates range from $50 million retail21 and $160 million retail.22 Sphere provided an estimate of total industry exports of $30 million ex-factory23, but this is difficult to quantify in retail terms. Manufacturers claim that retailers aim for an 800 –1000% mark-up but do not always get it. This paper assumes a 500% mark-up, giving a retail export sales figure of $150 million. This comes close to the $160 million retail estimate reported by the Expert Committee2, but is three times the CHC’s estimate of $50 million retail. Export markets Leading exporters supply markets in Asia (Japan, Malaysia, Thailand, Indonesia, Philippines, Singapore), New Zealand, USA, UK and the Middle East (see Table 4):

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Table 4 Geographic breakdown of exports Source Blackmores Cardinal Lipa Nutrition Care

Pharmaceuticals Sphere

Destination Malaysia, Thailand, Singapore, Indonesia, UK, New Zealand, expanding into Taiwan.

SE Asia (esp. Philippines and Malaysia).

Mainly Asia (Japan, Malaysia, Thailand), Middle East and USA.

Singapore and New Zealand. Expanding elsewhere in Asia.

Asia

Percentage of sales

14 25 5–10 5–10 Not stated

Date August 2005 August 2005 August 2005 August 2005 August 2005

Sources: • Blackmores 4th Quarter Announcement, August 2005; Blackmores communication, 20 September

2005 • Cardinal communication, 22 August 2005 • Lipa communication, 5 August 2005 • Nutrition Care Pharmaceuticals communication, 22 August 2005 • Sphere Healthcare communication, 4 August 2005. Asia remains a major export market. Asian countries offer proximity to Australia, expanding economies and a cultural acceptance of traditional medicines. Blackmores stated that it focuses on areas where the Australian regulatory regime is a benefit in entering the market24 and reports recent strong growth in Asia25. SUPPLY About 90% of raw ingredients (see Attachment B) are sourced overseas.26 Herbs While it is estimated that approximately half of the herbs used in Australia could be grown locally27, the domestic industry for plant extracts remains fragmented, with a large number of small growers.28 Reliability of supply is a key issue for many buyers, who choose to acquire product from reliable international sources (traditionally Europe and now also in China)29 in preference to uncertain supply from local providers.30 MediHerb is the largest purchaser and processor of herbs in Australia. More than 40% of herbs used in the company’s products are sourced from Australian and New Zealand growers.31 Cost issues Manufacturers stated that, when sourcing raw ingredients, they must ensure that key suppliers meet Good Manufacturing Practice (GMP) standards and that the ingredients the manufacturers purchased meet their quality assurance specifications.32 REGULATION CMs in Australia are regulated under the following legislation: • Therapeutic Goods Act 1989 • Therapeutic Goods Regulations 1990 (as amended)

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Product licensing All CMs must be entered (on application to the TGA) in the ARTG. Currently, about 16 000 are included. Regulation is on the basis of risk. Products can be either listed (low risk) or registered (higher risk). For a product to be registered, there must be independent clinical trials proving its efficacy and safety. This data must be submitted to the TGA for evaluation. Listed products only have to provide evidence of their safety (i.e. compliance with GMP, quality of product and absence of significant toxicity). However, the sponsor must be able to produce evidence as to their safety and efficacy on request. Most CMs are listed on the ARTG and some are registered. Good manufacturing practice All products must be manufactured in compliance with GMP. Site licensing The TGA licenses manufacturers and audits GMP compliance. Labelling requirements Registered medicines (higher risk) are identified on the label by AUST R followed by a unique number. Listed medicines (low risk) are identified on the label by AUST L followed by a unique number. Post-market regulatory activity The TGA takes a risk-based approach to post-market surveillance, which includes: • targeted and random desk-based audits of listed products • monitoring of adverse reactions • targeted and random laboratory testing of products and ingredients • targeted and random surveillance in the market place • an effective, responsive and timely recalls procedure • audit of GMP compliance • effective controls for the advertising of therapeutic goods. Regulation since the closure of Pan Pharmaceuticals (April 2003) • Therapeutic Goods Amendment Act (No. 1) 2003

Following the failure of Pan Pharmaceuticals Limited to meet the requirements of GMP, the Australian Government tightened the Therapeutic Goods Act 1989 to further ensure the quality, safety and efficacy of therapeutic goods that are supplied in Australia or exported from Australia.

The Amendments: – increased maximum penalties for a range of existing offences under the Act including

where there has been a failure to comply with standards, false statements made in applications for entry of goods on the ARTG (the Register), breach of a condition of a manufacturing licence (including failure to comply with the manufacturing principles), false statements made in a conformity assessment declaration and the counterfeiting of therapeutic goods

– created new offences for falsification of any document that has been created, retained or issued for the purposes of the Act and for supplying goods originating from a manufacturer or manufacturing site that has not been notified to the Secretary

– expanded the compulsory public notification and recall provisions which may be used where there is a problem with a product or its manufacture

– inserted a ‘fit and proper person’ test into the provisions for granting a manufacturing licence or conformity assessment certificate and suspending or revoking a manufacturing licence or conformity assessment certificate

– inserted new statutory conditions of licence to ensure compliance with the manufacturing principles and reporting of adverse effects known to a manufacturer;

– required sponsors of therapeutic goods to maintain records of all manufacturers involved in the manufacture of each batch of therapeutic goods and have them available for inspection at any time or risk cancellation of the goods from the Register, as well as requiring them to notify the Secretary of any change of manufacturer

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– provided for better identification of therapeutic goods in the event of a recall or where a sponsor applies for re-entry of previously cancelled goods on to the Register

– improved adverse event reporting for listed goods.33 • Therapeutic Goods Amendment Act 2005

This Act provided new enforcement options, in addition to those which were currently available under the Therapeutic Goods Act 1989, to enhance the TGA’s ability to better secure compliance with the Act to ensure that public health and safety are adequately protected. The intention of the legislation is to allow the TGA greater flexibility in applying sanctions for breaches of the Therapeutic Goods Act 1989. Previously, the TGA’s only options were to take criminal action or cancel a licence (or do nothing). Under the new framework, the TGA can take one of four options, depending on the seriousness of the breach – criminal action, administrative sanctions through the Federal Court (civil), a court-enforceable undertaking, an on-the-spot fine – as well as the option of licence cancellation. No new criminal sanctions were included. The new enforcement measures are intended to apply to all therapeutic goods, including prescription, OTC and complementary medicines, medical devices and blood.34

RESEARCH As with industry data, statistics on Australian CM research are not generally available. Dedicated researchers in CM began to appear only in the mid-1990s35, and a 2005 report to the NSW Government is the first to offer a clear estimate of industry and government funding.36 CM RESEARCH CENTRES CM research is carried out mainly in universities (see Attachment C). The major CM research centres in Australia are located in NSW and Queensland: • CompleMED, The Centre of Complementary Medicine Research, University of Western

Sydney • Herbal Medicines Research and Education Centre, Faculty of Pharmacy, University of

Sydney • The Australian Centre for Complementary Medicine Education and Research (ACCMER),

Southern Cross University and Queensland University A Victorian CM research centre, with State government funding of $500 000, is being established.37 Smaller research units in NSW include: • Natural Therapies Unit, Royal Hospital for Women, Sydney • University of New England, Division of Human Biology • University of Technology Sydney (UTS), College of Traditional Chinese Medicine • Charles Sturt University, Faculty of Health Studies.38 RESEARCH PRIORITIES Researchers suggest that research priorities should include: • managing chronic illness • preventive care • aged care • potential benefits and adverse effects of CMs and therapies • CM products that need to be modified or discontinued to bring them into line with

community expectations of acceptable risk. In a recent survey of 252 projects, 39% of funding related to western herbal medicine, 23% to traditional Chinese medicine and 19% to nutritional supplements.39

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RESEARCH FUNDING The last five years have seen more than $26 million invested in CM research in Australia. Industry has been the greatest contributor (approximately 40%), followed by Commonwealth Government sources (29%) and universities (21%). See Table 5. Table 5 Funding reported by CM researchers, government agencies and industry from all sources, 2000–2004

Source Number of projects

Research quantum ($millions)

Percentage of total quantum

NHMRCa 7 2.35 8.9 ARCb 8 1.9 7.2 Other Federal e.g. DESTc, AusIndustry

20 3.4 12.9

State Govt bodies 15 1.0 3.8 Industry 132 10.4 39.5 NGOd/charity 17 1.7 6.5 University/private college

54 5.6 21.2

Total 252 26.35 100 a National Health & Medical Research Council b Australian Research Council c Department of Education, Science & Training d Non-government organisation Source: A Bensoussan, S Myers, M Cooke & P Cheras. Review of Complementary Medicine in NSW. Report to the Ministry for Science and Medical Research, April 2005, p. 39. Industry Industry contributed $10.4 million to CM research in 2000–2004. Twelve major CM companies estimate that they contributed a total of $2.8 million to research funding and infrastructure during that period. Larger companies were more likely to conduct in-house research, commission external research and fund research positions in university research units.40 The research commitments (and benefits) of a major player, Blackmores, include: • a clinical trials program – including developing protocols, facilitating trials • research director located at Southern Cross University • support for ACCMER - currently in second year (2005-06) • at ACCMER, access to collaborative research, research students and commissioned

research • supply of product for vitaTOPS trial, a multi-centre trial based in Western Australia.41 Commonwealth sources Commonwealth funding agencies include: • National Health and Medical Research Council (NHMRC) • Australian Research Council (ARC) • AusIndustry, Department of Industry, Tourism and Resources • Department of Education, Science and Training (DEST). In 2000–2004, the NHMRC provided $2.35 million for CM research – 0.1% of the $1.68 billion research funds available to the NHMRC during that period. In both 2004 and 2005, the NHMRC did not allocate any funding to new CM research projects.42 Successful funding applications most commonly involved research relating to nutritional supplements, acupuncture and western herbal medicine.43

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In 2000–2004, AusIndustry allocated $2.7 million to CM research through its Biotechnology Innovation Fund (BIF). This represented about 8% of total BIF funding.44 AusIndustry also administers the broad-based R&D Tax Concession program that allows companies to deduct up to 125% of qualifying expenditure incurred on R&D activities when lodging their corporate tax return. It can be claimed only for systematic, investigative and experimental activities.45 The number of CM companies registered for the R&D Tax Concession is not known. Information on CM funding from DEST and CSIRO is fragmented, although DEST is known to have funded two Cooperative Research Centres (the CRCs for Asthma and Chronic Inflammatory Diseases) marginally related to CM research in the last five years.46 BARRIERS TO RESEARCH While it is likely that industry demand for CM research will increase due to regulatory pressures, researchers into CMs have claimed the following barriers to research remain: • inadequate government funding • limited financial capacity for the CM industry in Australia to support CM research • lack of capacity and infrastructure • lack of research training and expertise • the fact that many CMs are in the public domain • non-scientific explanatory theories underlying traditional remedies • methodological issues • lack of practitioner regulation.47 LOOKING AHEAD: ENCOURAGING INNOVATION & RESEARCH EXPERT COMMITTEE RECOMMENDATIONS (2003) The Expert Committee on Complementary Medicines in the Health System recommended that the NHMRC convene an expert working group to identify the research needs (recommendation 33) and that dedicated funding be made available for CM research in Australia for a minimum of five years (recommendation 34), with the amount determined on a per capita basis consistent with CM research funding in the US (recommendation 35). The Committee also recommended that: • a database be established to identify researchers and centres of excellence to facilitate

complementary medicine research in Australia (recommendation 36) • the TGA develop formal links with appropriate international centres involved in

complementary medicine research to facilitate coordination of research effort and minimise duplication (recommendation 37)

• organisations involved in awarding public funds for healthcare research ensure that: (a) applications for research funding in the area of CMs are assessed by fair, equitable

and ethical methods (b) the methods represent the best use of community resources to meet the current and

future healthcare needs of the community (recommendation 38) • the TGA convene a stakeholder group to identify incentives to encourage innovation and

research in CMs, including data protection and market exclusivity (recommendation 40).48 GOVERNMENT RESPONSE The Government has since accepted recommendations 33, 36, 37, and 40, noted recommendations 34 and 38, and rejected recommendation 35, explaining that ‘the Government does not consider that funding should be tied to a specific formula, but that it should be based on research needs, which are yet to be determined (see Recommendation 33)’. As an interim response to recommendation 34, the Government has announced funding of up to $500 000 to assess the value of glucosamine in the management of arthritis.49

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In September 2005, the Government announced funding of around $65 000 for research into the health benefits of complementary and OTC medicines, plus a commitment to undertake another study addressing the information and skills consumers need to take CMs responsibly.50 In November 2006, the Government announced a $5 million funding initiative through the NHMRC for researchers investigating the use and effectiveness of complementary and alternative medicines.51

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References 1 Cardinal Health. Vitamin, Mineral, Herbal and Nutritional Supplements, 4 October 2005. 2 Expert Committee on Complementary Medicines in the Health System. Complementary

Medicines in the Australian Health System. Report to the Parliamentary Secretary to the Minister for Health and Ageing. Canberra: Commonwealth of Australia, 2003, p. 43.

3 Complementary Healthcare Council communication, 13 September 2005. 4 ibid. 5 Regulation of Non-prescription Medicinal Products: Department of Health and Ageing

Therapeutic Goods Administration. ANAO Audit Report No 18 2004–05. 6 Therapeutic Goods Administration communication, 19 August 2005. 7 In April 2003, the Therapeutic Goods Administration initiated the recall of more than 1600

complementary medicines from the Australian marketplace. It was the largest recall of medicines in Australia and heightened interest in complementary medicines. The recall was a result of the failure of one medicine manufacturer, Pan Pharmaceuticals Limited, to maintain appropriate manufacturing and quality control standards. This led to an immediate market size reduction in terms of value of 20% (industry estimates).

8 ‘Post-Pan, there are fewer products on the market, but more of them are being sold’ (Blackmores communication, 20 September 2005). Cf B Foley, Collapse hasn’t stopped customers popping pills. Australian Financial Review, 26 February 2004: ‘After an immediate sales drop, most industry players are reporting a return to pre-Pan sales levels close to 12 months after the recall’.

9 See Medicinal and Pharmaceutical Product Manufacturing in Australia. IBIS World Industry Report C2543, 4 January 2005, pp. 5, 11.

10 A MacLennan, D Wilson & M Taylor. The escalating cost and prevalence of alternative medicine. Preventive Medicine 35, 2002, pp. 166–173.

11 J Eyers, Consumers still interested in the alternative view. Australian Financial Review, 26 February 2004.

12 Complementary Healthcare Council communication, 13 September 2005. 13 Medicinal and Pharmaceutical Product Manufacturing in Australia. IBIS World Industry

Report C2543, 4 January 2005, p. 12. 14 Lipa communication, 5 August 2005. 15 Blackmores communication, 20 September 2005. 16 Direct Selling Association of Australia (DSAA) communication, 25 August 2005. 17 Complementary Healthcare Council communication, 13 September 2005. 18 Direct Selling Association of Australia (DSAA) communication, 25 August 2005. 19 Cardinal Health. Vitamin, Mineral, Herbal and Nutritional Supplements, 4 October 2005. 20 Blackmores communication, 20 September 2005. 21 Val Johanson (Complementary Healthcare Council), in A bitter pill to swallow, The Age,

30 August 2003. 22 Industry estimate to Expert Committee, p. 37. 23 Sphere Healthcare communication, 4 August 2005. 24 Blackmores communication, 20 September 2005. 25 Blackmores 4th Quarter Announcement, August 2005. 26 Lipa communication, 5 August 2005. 27 Natural plant extracts: Export market opportunities in the USA. RIRDC Publication No

00/51, 2000, p. 12. 28 Julian Clark, Capacity to produce pharmaceutical products from agriculture. In New food

and pharmaceutical products from agriculture: Papers from Outlook 2002. RIRDC Publication No 02/015, 2002, p. 25.

29 See D McKinna, Curing the new industry syndrome. Proceedings of the 3rd National Herb, Native Foods and Essential Oils Convention, Workshops and Farm Visits, 14–14 August 2003, Lismore NSW. RIRDC Publication No 04/059, 2004, pp. 22–35; Blackmores communication, 20 September 2005.

30 D McKinna, Proceedings, p. 33. 31 MediHerb philosophy, www.mediherb.com.au 32 Cf Blackmores 2004 Annual Report, pp. 6–9. 33 See www.tga.gov.au/docs/html/tgaa0301.htm (accessed October 2005).

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34 See http://parlinfoweb.aph.gov.au/piweb/browse.aspx?NodeID=41 (accessed October 2005).

35 A Bensoussan , S Myers, M Cooke & P Cheras. Review of Complementary Medicine in NSW. Report to the Ministry for Science and Medical Research, April 2005, p. 23.

36 ibid. 37 P Komesaroff & K O’Brien. Victorian Complementary and Alternative Medicine Research

Feasibility Study: Final report. Melbourne: Department of Human Services, Victoria, 2002. 38 Bensoussan et al., p. 46. 39 ibid., p. 40. 40 ibid., p. 38. 41 Blackmores communication, 20 September 2005. 42 Bensoussan et al., p. 25. 43 ibid., p. 26. 44 ibid., p. 29. 45 ibid. 46 ibid., pp. 30–31. 47 ibid., pp. 51–52. 48 Expert Committee, pp. 145–146. 49 Government Response to the Recommendations of the Expert Committee on

Complementary Medicines in the Health System, Australian Government, March 2005, pp. 32–33.

50 Christopher Pyne, Self-care: a consumer’s choice. ASMI Annual General Meeting and Conference, Sydney, 21 September 2005.

51 '$5 million for research into complementary medicine', NHMRC Media Release, 23 November 2006.

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Attachment A ‘Complementary medicines’: Two perspectives from the Australian industry 1. The Australian Self-Medication Industry (ASMI) Complementary Medicine (sometimes also called Complementary and Alternative Medicine - CAM) cannot be defined in a single way. Sometimes, it is regarded as a set of modalities and procedures that can either substitute for or add to more “orthodox” Western medical practices. Sometimes these modalities are based on ancient and traditional forms of medicines used by indigenous cultures over many centuries, such as Traditional Chinese Medicine (TCM) and Ayurvedic Medicine. Sometimes it may refer to very modern approaches to healthcare that are still not adopted as “standard treatments”. Sometimes it may refer to the use of vitamins, minerals, biologically derived substances and herbal therapies that may be used in a symptomatic, preventative or holistic way. Sometimes it may refer to physical manipulative, psycho-spiritual or other therapies that engage in harnessing the connections between mind and body. Within context to the Australian non-prescription consumer healthcare industry, complementary medicines more often refers to those herbal, vitamin, mineral and other substances presented in a ‘pharmaceutical’ dose form – this may be a tablet, capsule, liquid, powder or other such forms. Such complementary medicine may also be known as “traditional medicines”, “dietary supplements”, “nutraceuticals”, “phytopharmaceuticals”, “herbal drugs” and other such terms. Source: www.asmi.com.au 2. Lipa Pharmaceuticals Complementary medicines (also known as alternative medicines or nutraceuticals) are classified as a sub-set of Over The Counter (OTC) pharmaceuticals. While there is no universally accepted definition of complementary medicines, in Australia this class of pharmaceuticals is generally accepted to include: • herbal medicines; • vitamins and mineral supplements; • other nutritional supplements; • traditional medicines; • homeopathic medicines; and • aromatherapy oils. Source: Lipa Pharmaceuticals Annual Report 2004, p. 10

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Attachment B Therapeutic Goods Regulations 1990, Schedule 14 Designated active ingredients, (Therapeutic Goods Act 1989, section 52F) Item Ingredient or kind of ingredient 1 an amino acid 2 charcoal 3 a choline salt 4 an essential oil 5 plant or herbal material (or a synthetically produced substitute for material of that

kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll

6 a homeopathic preparation 7 a micro-organism, whole or extracted, except a vaccine 8 a mineral including a mineral salt and a naturally occurring mineral 9 a mucopolysaccharide 10 non-human animal material (or a synthetically produced substitute for material of that

kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates

11 a lipid, including an essential fatty acid or phospholipid 12 a substance produced by or obtained from bees, including royal jelly, bee pollen and

propolis 13 a sugar, polysaccharide or carbohydrate 14 a vitamin or provitamin Source: www.tga.gov.au

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Attachment C CM research centres Research Centre Director Research

interests/activities Objectives External links

Australian Centre for Complementary Medicine, Education and Research (ACCMER) ACCMER is a joint venture between Southern Cross University and the University of Queensland. Source http://www.accmer.edu.au/research/index.html

Director: Prof Stephen P Myers Deputy Director: Dr Phillip A Cheras

Clinical Trials Laboratory science Surveys and analyses Social research Literature reviews

Providing an independent reference point built on strengths in research, innovation and teaching.

Centre for the Advancement of Food Technology and Nutrition School of Applied Sciences University of Newcastle Source http://www.newcastle.edu.au/school/app-sci/research/CAFTAN.htm

Head of School: Prof. Wayne Erskine

Quality management of medicinal herbs Evaluation of medicinal herbs, particularly from indigenous plants, for constituents with pharmacological properties; examination of growing conditions on active constituents. Identification of dietary components, especially from plants (phytochemicals), which exhibit antioxidant and cholesterol-lowering potential, determination of the biochemical and physiological mechanisms by which dietary components are protective against heart disease, development of new functional foods to lower the risk of heart disease in humans and determination

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Research Centre Director Research interests/activities

Objectives External links

of the prevalence heart disease risk factors in the local population. Investigations on biologically active material in medicinal herbs, role of functional foods in preventative health care, novel separation techniques for biological matrices, evaluation of indigenous health systems of the Asia-Pacific region.

Centre for Complementary Medicine Research (CompleMED) College of Social and Health Sciences University of Western Sydney Source http://apps.uws.edu.au/research/complemed/ apps.uws.edu.au/research/complemed/prospect.pdf (October 2002) http://apps.uws.edu.au/research/complemed/brochure.pdf (no date)

Director: Assoc. Prof. Alan Bensoussan Associate Professor: Godfrey Isouard

Interests CM, Western herbal medicine, nutrition, relevant analytical chemistry Activities Clinical trials Laboratory research Health policy research Postgraduate education

Understanding the nature and degree of community use. Conducting clinical trials that will be of value to the community and industry. Developing and promoting an evidence-based approach to research. Undertaking basic analytical science of value to the herbal industry. Developing guidelines to support the integration of value aspects into modern medicine. Promoting an understanding between complementary and medical practitioners and researchers with the aim of improving client care.

National Herbal Analytical Laboratory Campbelltown Chinese Medicine Clinical Research Centre, Liverpool Health Service Nepean and Concord Hospitals St George Division of General Practitioners University of NSW South East Sydney Area Health Service Private Practitioners Newcastle University Southern Cross University Victorian Department of Human Services

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Research Centre Director Research interests/activities

Objectives External links

Exploring the safe use of CM. Establishing collaborative research activities and links with appropriate national and international centres. Supporting and promoting postgraduate research. Promoting practitioner and public education. Promoting the products of the Centre’s research.

Australian Institute of Sport Complementary healthcare Council The Baker Institute International WHO Nanjing University of TCM Jiangsu Provincial Hospital, Nanjing Seoul National University Hong Kong Baptist University Kew Gardens, London Guys and St Thomas Hospital, London

Chinese Medicine Clinical Research Centre Liverpool Health Service Source http://apps.uws.edu.au/research/complemed/cmcrc/index.html

Directors: Prof. Felix Wong Assoc. Prof. Alan Bensoussan

Traditional Chinese Medicine and integrating Western and Chinese Medicine. The regulation and use of complementary medicine

Clinical Research Develop an evidence-based approach to TCM Conduct clinical research in women's health, with a view to expansion into other clinical areas. Education Enhance the transfer of practical skills and learning for students at the University of Western Sydney, the medical profession and other health professionals.

CompleMED, the Centre for Complementary Medicine Research. The South Western Sydney Area Health Service (SWSAHS)

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Research Centre Director Research interests/activities

Objectives External links

Provide relevant health education for the South Western Sydney community. Promote identified advantages of an integrated Chinese-Western model for medical research, education and treatment to the wider community.

College of TCM University of Technology Sydney Source http://www.science.uts.edu.au/centres/tcm/research.html

Acupuncture clinical trials on stress. Acupuncture clinical trial methodology. Acupuncture mechanisms in the treatment of inflammatory conditions. The Virtual TCM Clinic (research and development program) Pharmacognosy of Chinese herbs Comparisons between the theoretical foundations of Ayurvedic medicine and TCM Clinical demographics History and development of TCM Primary research in pulse diagnosis

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Research Centre Director Research interests/activities

Objectives External links

Primary research into the accurate location of acupuncture points

Faculty of Health Studies School of Biomedical Sciences Charles Sturt University Source http://athene.mit.csu.edu.au/%7Ejwilkins/research

Sub-Dean Research: Dr Jenny Wilkinson

Use, and attitudes towards, complementary therapies by various health professionals Attitudes towards complementary therapies & their use in reproductive conditions Biological activities of essential oils esp. those from Australian native plants Wound healing properties of honey and essential oils Developmental toxicology of herbs used in the treatment of morning sickness

Herbal Medicines Research and Education Centre (HMREC) School of Pharmacy University of Sydney Source http://www.pharm.usyd.edu.au/hmrec/research.htm

Executive Director: Prof. Basil D Roufogalis,

Research on herbal medicines, including their safety, quality, efficacy and mode of action. Education programs at undergraduate and postgraduate levels Continuing professional development for pharmacists, traditional Chinese medicine (TCM) and other relevant practitioners.

To meet the demands for expertise in herbal and complementary medicines from industry and the community, and health-care professionals in pharmacy, medicine and related areas. To develop programs in education and basic and applied research on herbal and complementary medicines, particularly in the area of safety, quality and efficacy of such products.

Major Sponsors ($100,000) Bionax Sponsors ($50,000) Blackmores Shimadzu University of Sydney Benefactor ($20,000) Thursday Plantation Supporter ($3,000) Stephen Hunter Pty Ltd

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Research Centre Director Research interests/activities

Objectives External links

Herbal medicines analysis (PhytoLaboratory Services). National Centre of information and resources in herbal and natural medicines. Overseas linkages in all areas of herbal medicines activities.

To promote cooperation and links between the pharmaceutical and herbal and complementary medicines industries, user groups and the University, and to obtain support from these bodies for the work of the Centre.

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RMIT Chinese Medicine Research Group (RCMRG) Source http://www.rmit.edu.au/browse;ID=fp46zcaom6cb

Head: Assoc. Prof. Charlie Changli Xue Deputy Head: Dr Chun Guang Li

To evaluate efficacy and safety of acupuncture and Chinese herbal medicine; and to promote public awareness of evidence-based Chinese herbal medicine and acupuncture practice

Research partners Alfred Hospital & Monash University, Melbourne Guangzhou University of Chinese Medicine, China Chinese University of Hong Kong, China

Cellulose Valley and School of Natural and Complementary Medicine Southern Cross University Sources http://www.scu.edu.au/schools/ncm/index.php?page_id=12&menu=4_18 2005 Postgraduate Research Prospectus ACCMER

Head of School & Clinical Education Director: Paul Orrock Director of Postgraduate Studies & Research: Dr Scott Hahn

Basic and clinical research in complementary and alternative Medicine botanical medicine phytotherapy, herbal pharmaceutics, pharmacognosy, pharmacology of natural products, toxinology, human nutrition, public health in complementary medicine, homoeopathy. Consulting is done by individual members of the school in all aspects of plant chemisty, biochemistry, clinical, sociological and applied aspects of herbal medicine, nutrition, homoeopathy

Cellulose Valley is a project of Southern Cross University focused on development of natural plant products for the Australian and overseas market.