Submission to the Complementary Health Care Taskforce By Assoc Prof Ken Harvey MB BS, FRCPA, AM On behalf of Choice (Australian Consumers’ Association) Public Health Association Australia (PHAA) Health Action International Asia Pacific (HAIAP) Friends of Science in Medicine (FSM) Submission to Complementary Health Care Taskforce Background The Australian Therapeutic Goods Administration (TGA) defines ‘complementary medicines’ (known as supplements in other countries) as vitamins and minerals, fish oil, Western herbal medicine, Chinese traditional medicines, Ayurveda (Indian) medicines, indigenous medicines, homeopathic medicines, probiotics and aromatherapy products. A recent Federal court case1 ruled that encapsulation in Australia of imported fish oil (from Chile) and Vitamin D (from China) did not qualify for the ‘Made in Australia’ logo as mere encapsulation did not represent ‘substantial transformation’ of a product as required under Australian Competition and Consumer (ACCC) Guidelines.2 Complementary Medicines Australia (CMA) argued that this decision will have significant detrimental impacts on the industry’s $1.2 billion export market and threaten a work force supporting a 4.9- billion-dollar industry. They noted that many consumers, especially those in the Asia-Pacific region, look for the ‘Made in Australia’ logo as proof of high quality, trusted, products synonymous with Australian complementary medicines. CMA argued that the ACCC criteria for ‘substantial transformation’ should be watered-down such that all finished medicinal products manufactured in Australia under GMP meet the definition.3 Four perspectives 1. Consumers Choice Set up by consumers for consumers, Choice provides Australians with information and advice, free from commercial bias.4 Choice fights to hold industry and government accountable and achieve real change on the issues that matter most. I have represented Choice on many government inquiries and consultations, I’m a past Board Member and I’ve been awarded Life Membership for services to the consumer movement. Country of Origin Labelling (CoOL) is a priority issue for Choice. In addition, Australian Consumer Law5 and the Therapeutic Goods Advertising Code6 both state that representations must be truthful, accurate and not misleading. Choice supports the ACCC CoOL guideline for complementary healthcare products. TGA Consumer survey During June and July 2018, the TGA conducted a survey of consumer opinion about complementary medicines.7 It employed a dual sampling methodology: a quota driven population-based sample (Panel) and an Opt-in sample sourced through known TGA contacts, networks and consumer stakeholders. 1 http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2018/2018fca1936 2 https://www.accc.gov.au/publications/country-of-origin-labelling-for-complementary-healthcare-products-a- guide-for-business 3 http://www.cmaustralia.org.au/Australian-Made-Issues 4 https://www.choice.com.au/ 5 https://www.legislation.gov.au/Details/C2015C00327 6 https://www.tga.gov.au/publication/therapeutic-goods-advertising-code 7 https://www.tga.gov.au/tga-consumer-survey-2018 Page 1 of 4 Submission to Complementary Health Care Taskforce There was a considerable gender and age difference between the two groups: females; Panel, 50% compared to Opt-in, 66% and age over 55: Panel, 33% compared to Opt-in, 50%. However, the groups did not differ in complementary use, around half of each sample reported they used these medicines. Across the range of measures relating to complementary medicines, 18-34-year olds consistently showed the highest level of nett agreement with the above statements and those in the 55-plus group show the lowest levels of nett agreement. The results for other medicines showed higher positive responses to the same questions reflecting the difference between the “light-touch” regulatory standards for complementary medicines compared to the higher standards applied for other medicines. Overall, the responses below showed considerable concerns by survey participants relating to statements about complementary medicines. An ongoing focus on addressing and responding to consumer concerns about complementary medicines was recommended. This survey also casts doubt on the assumption by CMA that Australian complementary medicines are regarded as high quality, trusted products. 2. Public Health Association of Australia (PHAA) PHAA is the principal Australian public health NGO working to promote the health and well-being of all Australians.8 Its mission is to drive better health outcomes through increased knowledge, better access and equity, evidence informed policy and effective population-based practice in public health. I’m a member of PHAA and active in their complementary medicine special interest group. The PHAA has the following position statement. Food labelling is needed to assist consumers to make healthy food choices and promote public health including, ingredient labelling and nutrition information panels (including added sugar), and interpretive front-of-pack-labelling (adopted 26 September 2018). The same “truth-in-labelling” principles should apply to complementary medicines. A draft policy on this topic is currently undergoing consideration (including CoOL). 8 https://www.phaa.net.au/ Page 2 of 4 Submission to Complementary Health Care Taskforce 3. Health Action International Asia Pacific (HAIAP) HAIAP is part of an independent global network, working to increase access to essential medicines and improve their rational use through research excellence, evidence-based policy advocacy, and strengthening the capacity and involvement of civil society in government decision making. It has been my privilege to work with many health activists in our region, learn of their struggles and share their expertise and solidarity. HAIAP want medicines to be evidence-based, address real health needs, affordable and promoted ethically, by both local and international companies. Regrettably, as shown in the appended presentation, very few Australian complementary medicines fit these criteria. 4. Friends of Science in Medicine (FSM) FSM as formed in 2011 to emphasise the importance of basing Australian health care on evidence, scientifically sound research and established scientific knowledge published in peer-reviewed journals of accepted standing. Valuing scientific rigor is especially important in an age where unsubstantiated health claims are rampant and scientific consensus is ‘imbalanced’ by the views of extremists. As of February 2019, FSM has more than 1200 leading scientists, clinicians, lawyers and consumer advocates as supporters. I am currently the President of FSM.9 We campaign against the unethical promotion of therapeutic goods and services to consumers. The former includes many complementary medicines, diagnostic tests and medical devices. The latter includes services offered by both registered and unregistered health professionals. We welcome and support well-conducted research into complementary medicines. Some traditional medicines have been found to contain valuable medicinal ingredients, which have subsequently been isolated, purified and used effectively to treat disease. Examples include salicylates and aspirin from willow bark, digitalis from foxglove, paclitaxel from the bark of the Pacific yew tree and artemisinin compounds used for drug-resistant malaria isolated from Traditional Chinese Medicine made from sweet wormwood. However, FSM deplores the current TGA “light-touch” CM policy settings: no pre-market assessment of most complementary medicines; sponsors trusted to select ingredients from the TGA’s low-risk list, manufacture under GMP, hold evidence for claims made. Even worse, there are no timely or effective penalties for regulatory breaches. The inevitable result is that around 80% of the TGA’s limited post-marketing reviews show regulatory violations (mainly no evidence to support claims made).10 Around 98% of published advertising complaint outcomes are upheld; many more complaints sent to the TGA have no published outcomes. Furthermore, low-risk does not mean no-risk, see: “60 Minutes: Health supplements could contain heavy metals, arsenic and even snow leopard”.11 Also, SBS Insight program on Vitamins and Supplements, to screen on 12th March 2019 at 8.30pm 9 https://www.scienceinmedicine.org.au/welcome-message/ 10 https://www.tga.gov.au/book-page/5-listed-medicines 11 https://www.9news.com.au/2019/02/10/01/53/60-minutes-vitamin-supplements-protein-shake-valerian- green-tea-health Page 3 of 4 Submission to Complementary Health Care Taskforce Even worse, research is discouraged; a better return on investment comes from industry spending money on promotional hype and celebrities. This makes it hard for consumers (and health professionals) to separate the evidence-based wheat from the hype-driven chaff. Another problem is that the TGA does not ensure that herbal products have active constituents, only the generic herb. For example, cranberry products are not standardised for concentrations of proanthocyanidins which prevent uropathogenic P-fimbriated E. coli from adhering to bladder cell receptors. This accounts for the extremely variable clinical trial results looking at whether cranberry products prevent recurrent urinary infection.12 In addition, a recent paper, “An evaluation of garlic products available in Australian pharmacies" noted considerable variation in allicin and s-allyl cysteine concentrations, two of the major bioactive organosulfur compounds