ABN 68 413 038101 .~t:~ ............... 207/13A Montgomery Street, (PO Box 744) Kogarah NSW 2217 DIRECT SELLING www.dsaa.asn.auIP 61 2 8567 6200 I F 61 2 9588 7441 ASSOCIATION OF AUSTRALIA The Chairman TGA Transparency Review Panel Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 Dear Mr. Pearce The Direct Selling Association of Australia is the relevant Industry Association for direct selling in Australia. The annual sales of our Members, at retail price, is approximately $1.6 billion and those of our Members involved in the sale of therapeutic goods represent a substantial segment of the Complementary Healthcare market in Australia. A list of our Members is attached. The Association strongly supports the current regulatory system for Complementary medicines, evidenced by our contribution over many years to Committees, Task Forces, Seminars, Discussion Groups and Reviews. We heavily promote the regulatory system and the TGA to our Members. The Association applauds the TGA in its march for greater transparency, will support positive and practical improvements to the Administration's current operations, and any meaningful future policies to improve transparency and public understanding of Australia's regulatory system. Current Performance Notwithstanding our comments above, we believe that the TGA should address its current performance in a number of areas before embarking on the path of new initiatives which may place a strain on current resources and activities. We cite the example of a Member who has applied for a new ingredient listing and who has been waiting two years for approval. Such delays add to the Member's operating costs, can be a barrier to trade and may stifle competition. The Productivity Commission Report No. 15 in August 2001 stated that "a fee for service is a direct charge for the provision of the service" and "the fee must reflect the cost of the service provided". In the example quoted above, the delay (two years) and the stop/start nature of the way the application has been handled has undoubtedly added substantially to>the cost of the application for both the Sponsor and the TGA. Since the application was for a fixed fee payable to TGA it is unlikely that the TGA can fully recover Its costs in the matter. Good Manufacturing Practice (GMPj While the current arrangements for GMP are clear and transparent, we believe that the TGA should seek more co operation with relevant overseas regulatory bodies, to reduce the cost burdens on Australian Sponsors. In particular, the cost of the GMP regulations is a substantial cost burden for small and medium enterprises. Greater or lesser transparency does nothing to alleviate that cost burden. The Current Website The consultation document states that "there are over 3.800 files on the website, with many files containing hundreds of pages of information". We believe that the current website is designed and managed principally for Industry and Sponsors and is not "Consumer friendly". The bulk of the information on the website is of a technical or academic nature which would not be understood by the average consumer. Furthermore, we believe that the average consumer would not be interested in such information. We are not confident that all of the information on the website is reliable or up to date and that would adversely affect a user's confidence in the site. An example is a section headed "Substances that may be used in listed medicines in Australia". It contains the statement that "this list was updated on 12 December 2007". If the TGA is serious about greater transparency and the interests of consumers, we believe It must simplify the information on the current website. We believe that consideration should be given to the establishment of a separate website for consumers. On this site the information should be simple, concise and in plain English. Consideration should also be given to incorporating other languages into the dedicated Consumer website, for example, Mandarin, Spanish, French and German. We believe that greater transparency will not be achieved without additional cost, and the separate consumer website will be part of that additional cost. The TGA should look for cost savings in other areas to fully or partly recover these costs. In some areas, we believe that the existing website may be too transparent. For example, the free text indications do not necessarily assist consumers and more resources should be devoted to developing the coded indications area. We point out that many products more than ten years old were listed when there were no guidelines for evidence. Sponsors applied for listing in good faith, in accordance with regulations in place at that time and therefore, the quality of the free text indications would be variable for such medicines. At that time, free text was not available to the general public. Internal Guidance Documentation -Internet We agree that placing on the internet a larger range of guidance documentation used by TGA staff when involved in decision making activities would improve 2 transparency and would be of great value to those dealing with the TGA on a regular basis. Products Added or Removed from ARTG We would support the publication of information relating to the addition or removal of products from the ARTG but subject to the preservation of commercially sensitive information. Post Market Safety Investigations We believe that caution should be exercised when publishing the results of post market safety reviews. The recent publication of reviews of products containing Ginko is an example. We understand that the tests were conducted on a small number of products compared with the much larger number of Ginko products on the market. The published information did not adequatelY disclose the testing methods used, the dosage form of the products, or whether the tested products contained any other substances. We believe that total transparency should be the target when publishing information of this nature. Newsletters In the discussion document there is reference to "the newsletters that are produced". We are not aware of any regular newsletters sent to our Sponsor Members. In any event, we don't see how an expansion of the range of content in newsletters would benefit the Consumer. We believe that the dedicated consumer website, mentioned above, would be a more appropriate way to improve transparency for Consumers. Another way to improve transparency for Consumers may be the publication of a "take away" leaflet for distribution through pharmacies, health food stores and supermarkets. Such a leaflet should be in plain English. Other Jurisdictions We mentioned above the delay being experienced by a Member in having a substance approved for listing in the ARTG. The particular substance was approved for listing in both Australia and New Zealand as part of the Trans Tasman Arrangement (TI) but those approvals lapsed when the TI proposals were terminated. We believe that the TGA should more readily recognise the regulations in other respected jurisdictions (not only New Zealand) and accept for listing a substance which has been approved for use in one of those other jurisdictions. Conclusion When considering the proposed improvements in transparency, we believe the TGA should look closely at its service levels. It may be fair to say that the consumer is the TGA's principal stakeholder. It may also be fair to say that Industry in general is a client rather than a stakeholder, and we believe that the service levels provided to a client in a cost for service situation should be constantly monitored to ensure that the services are delivered in the most efficient, timely and cost effective manner. 3 We will be pleased to discuss any of these matters with you should you so desire. If you wish to do so, or require any further information, please contact Les Dell on 0285676200 or [email protected]. Sincerely, Les Dell Government & Public Relations 9 February 2011 4 .~t:............ ...... ..... \.. ..... 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