In essence the report [PDF] slams regulation by the Therapeutic Goods Administration (TGA), the Australian counterpart of the US FDA. It is eerily reminiscent of criticisms voiced over the past decade and in studies of 'light touch' pharmaceutical regulation such as the excellent Reputation & Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton University Press, 2010) by Daniel Carpenter.
The ANAO notes that -
Some two‐thirds of all Australians use complementary medicines — also known as ‘traditional’ or ‘alternative’ medicines— including vitamins, minerals, herbal, aromatherapy and homoeopathic products. Popular examples of complementary medicines in Australia include fish oil, St John’s Wort and glucosamine. These and many other complementary medicines are generally available for self‐medication by consumers. There are about 10 000 such medicines available on the Australian market. Consumption has continued to rise in recent years and, together with increasing exports of Australian‐manufactured complementary medicines, market growth has been estimated at between 3% and 12% a year. Sales of complementary medicines in Australia were estimated at $1.2 billion a year in 2010. Similar growth has been observed across other industrialised countries and the global market has been estimated at $US 83 billion annually.The ANAO concludes that -
Growth in the use of complementary medicines has been attributed to concerns about adverse effects from conventional drugs and the desire to pursue alternative treatments. These medicines are also widely considered to offer a gentler means of managing chronic conditions associated with greater life expectancy. However, there are potential risks as well as benefits in the use of all medicines, including complementary medicines, and this is recognised in Australia’s National Medicines Policy (NMP).
The community expects medicines on the Australian market to be safe, of good quality, effective and to be available promptly. The Commonwealth regulates complementary medicines, along with other therapeutic goods (medicines and medical devices) through the Therapeutic Goods Act 1989 (the Act). The object of the Act is to provide for a system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods. The Minister for Health & Ageing has responsibility for the Act and the
Therapeutic Goods Administration (TGA), part of the Department of Health & Ageing (DoHA), has the regulatory role.
The TGA has operated over the last two decades with an evolving regulatory framework. The Act has been amended frequently since it came into effect and the regulation of complementary medicines has changed, generally to provide easier market access for the low‐risk category of these products. An important development in this respect was the introduction, in 2001, of a system of self‐assessment for certifying that low‐risk complementary medicines satisfy the regulatory requirements that allow them onto the Australian market. Consistent with the view that such complementary medicines are low‐risk, this mechanism provides only limited assurance to the public about the characteristics of these medicines.
The TGA’s regulation of complementary medicines attracted attention in 2003 when it recalled more than 1600 products manufactured by Pan Pharmaceuticals, then Australia’s largest contract manufacturer of complementary medicines. The Government subsequently appointed the Expert Committee on Complementary Medicines in the Health System (the Expert Committee) to review the regulation of these medicines. The ANAO also undertook a performance audit of the TGA in 2004, focusing on the regulation of non-prescription medicines (which includes complementary medicines). The review and the audit report generated a number of recommendations for change, almost all of which were accepted.
A substantial change to the governance of therapeutic goods regulation was planned for mid-2006 with a project to introduce a joint regulatory agency for therapeutic products in both Australia and New Zealand. After extensive preparation, the project was suspended in mid‐2007 when the New Zealand Government announced it was not proceeding with the legislation. Regulation of complementary medicines was the stumbling block to implementing the joint scheme at this time. This initiative has recently been revived by the prime ministers of Australia and New Zealand.
The regulation of complementary medicines came to public attention in Australia when DoHA reported in late 2010 that, based on 2009–10 data, as many as 90 per cent of products reviewed were found to be non‐compliant with regulatory requirements, despite the system of self‐assessment by sponsors. Among the medicines the TGA reviewed, 31 were selected at random, for which the following compliance issues were recorded (with a number of products recording multiple breaches):• 20 medicines had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers.A significant number of products subsequently required removal from the ARTG. This information was contained in DoHA’s incoming government brief, which was released to the public in late 2010. The information in the brief attracted significant interest and debate on the topic has persisted.
• 12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
• 22 were found to have manufacturing and/or quality issues.
• 14 did not have adequate evidence to substantiate claims made about the medicines
The system for the regulation of complementary medicines in Australia was designed to have a ‘light touch’, due to the relatively low risk ascribed to the proper use of the majority of complementary medicines. The regulatory system has been further amended since its inception, twenty years ago, to ensure that market access for these products is not impeded unnecessarily. Because market access has been made easy, quick and low cost, an important safeguard to the integrity of the regulatory system is that easy entry be balanced by an effective post‐market monitoring of compliance with regulatory requirements that is commensurate with the relatively low risk profile of these products.
The results of TGA post-market monitoring in recent years have shown that non-compliance by sponsors of complementary medicines with regulatory requirements has been consistently high. In 2006, on the basis of a random sample, the TGA found a non‐compliance rate of 75%. DoHA has recently reported non‐compliance as high as 90% for the products reviewed. While the recent data is based on small sample sizes, making it difficult to gauge the magnitude of non‐compliance with any precision, TGA figures nevertheless show that a high level of non-compliance has endured for some years and that a substantial proportion of the cases of non‐compliance are categorised as ‘moderate’ or ‘significant’. The TGA has expressed concern that this situation presents potential risks to the public, the industry and confidence in the regulatory system. In this context, the available evidence indicates that the regulation of complementary medicines in Australia has been of limited effectiveness. The administration of the regulatory framework could be strengthened by the TGA making changes to improve the integrity of the self‐assessment process for pre‐market listing, using a risk‐based approach to better target its post‐market reviews, and improving the transparency of information available to consumers, health professionals and industry.
Listing new medicines was intended to be based largely on self-assessment by the sponsor of the medicine. However, risks arise in the operation of this self-assessment model because it permits inappropriate or misleading claims and indications to be made by sponsors through the deliberate or inadvertent entry of information in the ‘free‐text’ field of the TGA’s online Electronic Listing Facility (ELF). Given the importance of self‐assessment to listing new medicines, placing restrictions on the ability of sponsors to enter free text in ELF would mitigate the risks, while maintaining the promptness and ease of listing. The TGA is currently progressing work on a ‘coded indications’ project to this end and the ANAO has recommended that this project be finalised as soon as practicable.
At present, the TGA does not use in any systematic way the knowledge it gains from post‐market reviews of complementary medicines listed on the ARTG to identify and target consistent non‐compliance with the regulatory framework. There is a significant opportunity for the TGA to cost-effectively strengthen its post‐market review activities. Improved analysis of existing information could inform a more targeted and risk-based approach to monitoring non‐compliance. In particular, the ANAO recommends that the TGA use its random sampling review of listed medicines to develop risk profiles against the most significant characteristics of listed medicines and the less compliant sponsors and manufacturers. These profiles would inform the TGA’s targeted review strategy and enable it to direct efforts into improving compliance on a risk basis, whether through providing information or education to sponsors or, where necessary, through regulatory action. Against the background of 3000 sponsors and 10 000 listed medicines, a risk‐based approach to compliance monitoring has the benefit of directing limited resources to those products presenting the greatest risk of non‐compliance. The TGA could also benefit from developing a more active, but targeted, approach to monitoring compliance with advertising requirements, with options to be considered in the context of developing the risk profiles.
The Government’s recent review of the transparency of the regulatory framework was prompted by concern about the lack of information made available by the TGA about its regulatory processes and decisions. That review examined what information should be made more public and made recommendations about how that information could be better conveyed. The ANAO has concluded that transparency could be strengthened significantly by making information available in a timely manner to the Australian public for each listed complementary medicine, stating whether it has been subject to post‐market review, when, and the outcome of that review. The options for doing so include the provision of information on the TGA website, such as by adding fields to the publicly-viewable elements of the ARTG.
The most challenging aspect of regulating complementary medicines, which also affects the transparency of the system as a whole, is the public availability of evidence relating to their efficacy. It has been government policy since March 2005 that the TGA collect a summary of evidence from sponsors, an item which sponsors were required to hold when listing their medicine. The TGA developed an understanding that the requirement would be legislated in the context of the ANZTPA project but implementation faltered after the suspension of that project. In the course of the audit, the TGA advised that it had taken steps in May 2011 to restart implementation of this policy.
In summary, the regulatory framework for complementary medicines is important for consumers, health professionals and industry, and is now operating in the context of a growing domestic and international market with numerous sponsors and listed medicines. The effectiveness of the TGA’s administration of the framework would be improved by limiting the capacity which currently exists for sponsors to enter inappropriate claims as part of the pre‐market listing process, adopting a risk‐based approach to compliance monitoring and by implementing the existing government policy that the TGA collect a summary of evidence of efficacy for each listed complementary medicine. The public release of those summaries would have the further benefit of improving transparency by making relevant information available to consumers and health professionals about the effectiveness of complementary medicines. The ANAO has made five recommendations aimed at strengthening the integrity and transparency of the framework within existing policy settings, in large measure by refining the TGA’s existing systems and processes and better targeting the utilisation of resources.
