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Consultation: Improving advertising arrangements for therapeutic goods Arthritis Australia response ISSUE Comments from Arthritis Australia Questions for consideration Should the Therapeutic Goods Administration (TGA) publish on Arthritis Australia (AAust) supports publication on the TGA website its website information related to products removed from the of products which have been removed from the Australian Register of Australian Register of Therapeutic Goods (ARTG)? Therapeutic Goods (ARTG). In order to enhance the transparency of regulatory processes, it is The TGA website should also list products which have had sanctions or proposed that the TGA will regularly publish on its website those incurred penalties, but retained their listing on the ARTG. This will act as products that have been removed from the ARTG as a result of a a more effective deterrent against transgressions. regulatory decision. The TGA should create an email alert service which interested parties can sign up for online. This is a low cost way to keep consumers, health professionals and retailers appraised of products which have been removed or had sanctions taken against them. A consumer who started buying a product because of a false claim has a right to know the truth, so that they have an opportunity to change their behaviour. The approach by the TGA needs to be more proactive and not rely on people to continually check the website for updates. The TGA should implement multiple strategies, in addition to the ones suggested above, to inform health professionals, the retail channel and consumers of any breaches. The TGA should also list on their website those ARTG listed products that are currently under review or re-evaluation. AAust supports the creation of independent Complaints Resolution Should the Complaints Resolution Panel (CRP) be reconstituted as an Panel (ICRP). independent body? Members should be independent because most complaints are related to Currently the CRP is made up of nominees from industry members of industry associations. There should be an advertisement in associations, professional organisations, peak consumer national newspapers calling for nominations from the community, organisations and the TGA, and has an independent chair. professional organisations, industry and academia for membership of the Virtually all complaints considered by the CRP are related ICRP. to members or potential members of the industry The ICRP needs to be provided with resources to respond to complaints associations represented on the Panel. in a prompt and efficient matter. A complaint should be forwarded to the ISSUE Comments from Arthritis Australia If an independent complaints resolution body is to be manufacturer of the product in no more than five working days. This maintained, any perceptions of conflicts of interest could be gives an opportunity for a manufacturer to address an issue quickly addressed by requiring members to be independent of the before a ruling has been made about the complaint. therapeutic goods and advertising industries. If the ICRP takes weeks or months to review a complaint and then makes a ruling, then the damage has already been done. The ICRP should make a ruling, which can still be appealed, in no more than 15 working days. A consumer may spend years and thousands of dollars purchasing an ineffective product based on a false claim. The ICRP must act quickly to prevent this happening and make the financial penalties far outweigh the potential financial gain from breaches. The complaints process needs to focus on minimising the potential exposure to consumers of misleading or false claims. There should be incentives, including reduced sanctions, for manufacturers who swiftly address a breach before the ICRP has made a ruling. There is a need for guidelines, with appropriate compliance monitoring, for word-of-mouth promotion of products to all health professionals. Should the CRP consider complaints about all forms of advertising? All forms of advertising should be covered by the ICRP including online, websites and in store promotion. Some media for non-prescription medicines and medical devices Health claims made on packaging and labelling should be considered are within scope of the CRP's oversight e.g. print, radio and advertising. The place a consumer is most likely to see and be influenced television, but others are currently exempt e.g. in-store by an advertising message is at point of purchase. Any information that promotion. appears on a complementary medicine product and packaging is a form Many complaints handled by the CRP are essentially trivial of advertising and should be reviewed by the TGA or its representatives. and straightforward and may be better dealt with in Any complaint regarding claims made on packaging and labelling should another way. be reviewed by the ICRP. Minor, trivial or straightforward complaints can be dealt with by employing full time ICRP officers. Only complaints of a more serious nature or those that cannot be resolved should be forwarded to the newly formed ICRP. If a party makes a complaint to the ICRP, they should be informed of the outcome of the investigation and any action taken. ISSUE Comments from Arthritis Australia Should civil penalties apply for breaches of the regime? Penalties need to far outweigh any potential benefit. Civil penalties and More broadly, there are no provisions for seeking civil penalties enforceable undertakings should apply for breaches of the regime. This or enforceable undertakings for breaches of the advertising will act as an effective deterrent and help prevent many potential provisions of the Legislation. breaches. Any revised sanction and penalty arrangements need to provide a Revised sanction and penalty arrangements need to provide a regime that regime that is both a real deterrent against transgression, and is a real deterrent against transgression as well as ensures the effective ensures the effective remediation of advertisements that are found correction of advertisements that are found to be in breach. to be in breach. The TGA should be given the power to refuse to list a product The sanctions regime under the legislation could be that was substantially similar to one that had been cancelled strengthened to include civil penalty contravention unless and until the relevant remedial action had been taken. provisions and court-imposed remedial action for advertising For a serious breach, the company which manufactures the product breaches. should be required to advertise their correction in the media including The TGA could also be given the power to refuse to list a product publications read by health professionals. that was substantially similar to one that had been cancelled The ICRP should have the resources and power to investigate breaches unless and until the relevant remedial action had been taken. not just responds to complaints. The increased revenue from the significant increase in penalties and sanctions could be used to fund investigations. Additional recommendations from Arthritis Australia New system for classification Arthritis Australia proposes that all complementary medicines contain a simple classification system that informs consumers and health professionals of the safety and efficacy of a product. Consumers have the right to make informed decisions about health risks and the scientific evidence surrounding a product. Arthritis Australia has based its classification system on the Arthritis Research UK system of classification. Find attached Alternative medicines for the treatment of rheumatoid arthritis, osteoarthritis and fibromyalgia - A report by the Arthritis Research. AAust is not advocating that the results from the UK study are adopted, just the classification system. Safety classification A false perception exists among some consumers that complementary medicines pose little or no health risk and have no side effects. Consumers are currently advised that ‘if symptoms persist, consult your health professional’. This does not address complementary medicines that pose a health risk or may interfere with the efficacy of prescription medications. Consumers do not always consult with their health professionals. Complementary medicines require a consistent safety classification which consumers can easily understand and identify. AAust proposes that all compounds be categorised according to their safety profile by using a traffic light system. Where information is available the compound would be categorised on the assumption that it is being taken within the range of recommended doses. Compounds which are safe at the recommended doses may have serious adverse effects when taken at higher doses. It should be emphasised to consumers that most conventional medicines have adverse effects, some serious. The proposed categorisation is: Traffic light at green Compounds with reported adverse effects which are mainly minor symptoms and infrequent. A classification of green does not mean that the compound has no reported adverse effects. Traffic light at a mber Compounds with reported adverse effects which occur frequently (even if they are mainly minor symptoms) or with more serious adverse effects. Traffic light at red Compounds with reported serious adverse effects. Consumers should carefully consider these before deciding whether to take these medicines. Scientific evidence effective classification When consumers see claims like ‘clinically tested’ or ‘clinically proven’, how can they be expected to determine if this claim is really evidence-based. The scientific evidence surrounding complementary medicines varies significantly; from the available evidence suggesting the compound is not effective to indicating that there is consistent evidence the compound is effective. The quality of randomised controlled trials (RCTs) can also vary significantly in quality. Arthritis Australia proposes a new rating for scientific evidence where effectiveness is measured by improvements in pain, movement, or general well-being using the Jadad system for rating RCTs. This scoring system is commonly used to evaluate the quality of published RCTs in the field of complementary medicine. The Jadad scale has levels from 1 (very poor quality) to 5 (very good quality). For simplicity of reporting:-
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