06 Jan 2015
Therapeutic Goods Administration review
In January 2011, the Australian Government announced a review into the transparency of the Therapeutic Goods Administration (TGA).
The TGA is the Australian regulatory body that is responsible for assessing and approving new medicines and medical devices (known collectively as therapeutic goods) for use in Australia. All medicines and medical devices must be approved for use by the TGA before they can be made publicly available in Australia.
The review into transparency looked at how the TGA can better communicate information about its decision-making processes and the benefits and risks of therapeutic goods to the Australian community, so that Australians can understand how the TGA operates and the reasons for its key decisions.
The Review Panel published its final report on 20 July 2011. The report includes 21 recommendations aimed at improving the transparency of the TGA.
The Report acknowledged that while the TGA had done much in recent years to increase knowledge about its role and functions, it was apparent that the expectations of the public are not being met and that there is more that the TGA can do to improve public understanding of its work. It found that the TGA needs to recognise that it serves many stakeholders, and that consumers and health practitioners have as much interest in therapeutic goods as the industry that produces and markets those goods.
Recommendations that would particularly benefit consumers, including women with breast cancer and their families, include:
- The establishment of a dedicated communications team within the TGA, whose role would include the development and implementation of a comprehensive communications strategy to inform and educate the public about the TGA’s role and processes
- The provision of user-friendly information explaining how different classes of therapeutic goods are evaluated, including detailed explanations of the different processes for registered medicines and listed medicines
- The development of strategies to ensure that consumers understand that listed medicines (which include complementary medicines) are not evaluated for effectiveness by the TGA prior to being approved for sale in Australia
- Improved labelling and packaging requirements to ensure consumers and health professionals are able to make informed decisions about the use of therapeutic goods
- Improved information about the TGA’s processes for regulating the advertising of therapeutic goods, including the complaints process and the outcomes of complaints
- An improved TGA website which is current, accurate, relevant, timely and up to date, and meets the needs of all of its audiences, including consumers
The recommendations addressed many of the points BCNA raised in our submission, including:
- The need for a consumer-friendly website that provides information relevant to consumers in a format they can easily access and understand
- An explanation of the differences between registered and listed medicines, and how they are assessed by the TGA
- Information on how consumers can lodge a complaint with the TGA about misleading advertising of therapeutic goods
- Better and more timely communication about matters relating to therapeutic goods, such as product alerts and recalls.
Our submission also raised our concerns that women being treated for breast cancer sometimes don’t realise that there may be an interaction between their conventional breast cancer medicines and complementary medicines they may be using or considering. We proposed that information on possible interactions be included on the TGA website. The Review Report addressed this issue in its discussion under Recommendation 2, stating that:
‘there are possibilities for increased collaboration with … consumer groups and specific health groups to actively engage in addressing emerging issues for those groups, which can range from access to emerging therapeutic options, to interactions between the prescription and complementary medicines, or unsubstantiated therapeutic claims (advertising)’.
The discussion under Recommendation 5 noted another of the concerns that BCNA had raised – that women do not always discuss their use of complementary medicines with their doctors.
BCNA welcomes the Report’s recommendations and urges the Australian Government to accept and implement all those that will help to improve consumers’ understanding of the TGA, its work and processes, and the way in which medicines are evaluated, or not evaluated, for use in Australia.
To read the report, including the 21 recommendations, visit the Review Report page on the TGA website.
BCNA made a submission to the review, outlining the sorts of information women with breast cancer have told us they look for in regards to their medications and how they want to access it (see download below).
Our submission also noted our concerns about the way in which some complementary medicines are approved for use in this country. As these types of medicines are not generally considered to be 'high risk' medications, companies lodging applications are able to 'self-assess' their product and are not required to provide the TGA with evidence of the effectiveness of the medicine at the time of registration. We are concerned, therefore, that some of these medicines may not be as effective as is claimed and that women may be spending large amounts of money on complementary medicines that are of no real benefit to them.
We also know that some complementary medicines can interfere with conventional breast cancer medications and can reduce their effectiveness (for example, some vitamin supplements and herbal and homeopathic remedies). We think women should be able to easily find information about the effects complementary medicines can have on their breast cancer drugs so that they can make informed decisions about whether or not to use these medicines.
Our submission also outlined our concerns about the code of conduct for advertising of therapeutic goods, and the process for lodging complaints about misleading advertising.
BCNA acknowledges and thanks the following BCNA Advocates for their assistance in producing this submission:
- Geraldine Robertson (ACT)
- Judith Maher (NSW)
- Gerda Evans (Vic)
- Avis Macphee (Vic)