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:-