2 December Dear Professor Pearce. Re: TGA Transparency Review

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1 2 December 2010 Dear Professor Pearce Re: TGA Transparency Review I congratulate you on your appointment as Chair of the stakeholder panel for the Review of Transparency of the Therapeutic Goods Administration (TGA). The Consumers Health Forum (CHF) welcomes this review which provides the opportunity to achieve a greater level of transparency and accountability in the regulation of therapeutic goods in Australia something that will be of significant benefit to Australia s health consumers. CHF acknowledges that the TGA is undergoing a process of reform to achieve greater efficiency, effectiveness and communication of its operations. We welcome these reforms and the willingness of the TGA to embrace necessary change management that can provide better information and services to consumers. CHF believes the core mission and role of the TGA is to monitor and regulate therapeutic goods in Australia. This is a critical component of Australia s health system and vitally important to health consumers. In the view of CHF, the capacity of the TGA to fulfil this role is significantly impeded by the following issues, all of which have been raised by health consumers for over a decade: 1. TGA s public profile and branding The TGA is not an active participant in the ongoing and important public dialogue about therapeutic goods, their safety and their regulation often we hear from key media outlets that they sought comment from the TGA

2 but none was forthcoming. This tendency to secrecy undermines credibility and confidence in the TGA, particularly when the provision of accurate and timely information is so critical to quality health care. The website is an example of what is often described as an inhospitable public face - too complex and bureaucratic, contains too much information and is hard to navigate. CHF has welcomed the review of the TGA website and has provided support to the review. The need for the website redevelopment to be adequately resourced is important. TGA to reconsider their public profile; their role in providing the public with information (the move to putting CMI and auspars on the website is positive but is one step towards this); the level of accountability and transparency to health consumers as the primary client. 2. Industry can be perceived as the client rather than consumers The structure (100% cost recovery) and processes within the TGA (including the level of consultation with industry), support the perception that TGA works for the industry. This is compounded by the lack of engagement by the TGA in public discussions about safety and regulation. It can be seen to confirm the perception that the therapeutic goods industries are the client of the TGA, not consumers. As an example, complementary medicines and devices are generally not evaluated by the TGA and the summary information promoted by producers can often be at odds with independent sources. TGA to ensure accurate, evidence-based information is included in all therapeutic products, and engage in an active review of public summary documents to ensure only evidence based claims are made in promoting therapeutic products.

3 3. The black box approach to decision making The TGA can be seen as lacking transparency and accountability the TGA seems to operate on the basis that their decision making requires a confidential expertise approach. As a consequence, the clinical basis for decisions are not often made clear to the public. The recent fluvax issue for children under 5 is a good example of this. The public should have been made aware of the basis on which the decision to provide influenza vaccination to children under five was taken given that clinical trials in under 5s are not practical. As this decision came before a World Health Organisation ruling, it was important for the grounds for approval be made clear to parents. The closed approach (not providing this information) was compounded by lack of public engagement or effective monitoring. The unfortunate circumstances that followed served to undermine the confidence of consumers in public vaccination programs. There is a need for public assurance that greater post-market surveillance is put into place when new and unproven medicines and vaccines are put onto the market. Parallel advice to clinicians about limitations of the evidence needs to be provided. The public have a right to know about limitations of evidence so they can make an informed choice. 4. Ineffectual monitoring Monitoring is critical to all systems, particularly in service areas like health. The TGA does not actively engage health consumers in monitoring. The views of consumers, the real customers of any regulatory environment around therapeutic goods, are not actively sought or used by the TGA. This diminishes the quality of monitoring, follow-up and accountability.

4 A rigorous post-market surveillance system needs to be developed, ideally data-linked real time monitoring systems involving the Commonwealth, State and Territory authorities which includes reporting by clinicians, sponsors AND consumers. It should be easy to access (for health consumers and others), and the TGA should respond to the issues raised through monitoring. Ineffectual sanctions There are three core principles in deterrence: you have to believe there is a good chance of getting caught; you have to believe there are unavoidable and serious consequences if you are caught; and you have to believe the community does not support your offending behaviour. While the last of these principles may be in place in the case of faulty or misleading therapeutic goods manufacturing and marketing, the first two conditions are not fully satisfied by current TGA processes. The lack of appropriate monitoring combined with limited penalties mean the TGA is not as effective a regulator as it might otherwise be. A list of product deletions should be kept on the website including reasons for delisting; other methods to promote enforcement actions should be pursued including regular TGA updates; complaints logged on the website; and public reports detailing timely complaints management. In summary The TGA has the potential to become a strong transparent organisation with a credible public profile (authoritative source of information) and an effective monitoring and feedback process in place for all therapeutic goods. The mission statement of the TGA safeguarding public health and safety in Australia by... must match the reality. Other regulatory bodies around the world have made reforms to fulfil the expectations involved in this kind of role.

5 The Food and Drug Administration (FDA) in the United States for instance has, over the last few years, moved toward greater transparency in its activities and decision making, enabled the public to better understand FDA decisions and in doing so, increased credibility, promoted accountability, and become more effective in protecting and promoting public health. CHF acknowledges that many of the solutions outlined need resources and that bodies like the FDA have significantly more resources to run a therapeutic goods list comparable to Australia s ARTG with 17,000 staff to TGA s 500. Finally, it is important to consider the structure of the TGA. The current structure (TGA is a division of the Department of Health and Ageing) may be contributing to some of the issues outlined in this brief summary. Many of CHF s members have questioned why the TGA would not be a statutory authority, operating in a capacity similar to other bodies requiring a level of independence from Government such as the National Health and Medical Research Council. Other health regulatory agencies appear to be better able to operate with transparency and accountability to the public within a statutory authority structure eg Private Health Insurance Administration Council. Failure of the TGA to fulfil the fundamental role of a credible and effective monitoring and regulatory body will undermine public confidence in Australia s therapeutic goods regulator. The CHF are confident that this review might lead to some long overdue action on the issues outlined in this document. I look forward to the first meeting of the stakeholder panel on Tuesday 7 December Yours sincerely Carol Bennett Chief Executive Officer