Complementary Healthcare Council Sydney 25 March 2009
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25 March 2009
I would like to acknowledge the traditional custodians of the land and pay my respects to the Elders both past and present.
Good morning to you all.
Thank you, Dr Wendy Morrow, Executive Director of CHC, and thank you to the Complementary Healthcare Council for providing this forum and for this opportunity to talk with you.
The TGA’s regulatory framework can at times appear quite complex to sponsors, health practitioners and consumers. It covers an incredibly wide range of medical products and services. It provides surety measures at each step in the development, marketing and monitoring of these goods. Pharmacovigilance is just one important part of the safety net we administer.
Over the next two days you will explore aspects of this framework.
Pharmacovigilance for complementary medicines is particularly complex and challenging. The multi-component nature of the medicines is a factor, as is the pervading consumer belief that complementary medicines are unquestionably safe however they are used. This potentially delays establishing a link between a product or ingredient and an adverse reaction. A history of relatively safe use of a particular herb, for example, must be balanced against the potential impact of newer preparations that are emerging, and the contextual implications of historical versus modern use.
In any case, officers from the Therapeutic Goods Administration are here today, and I note that Michelle McLaughlin will discuss the detail of pharmacovigilance and your requirements under the Act.
This morning I want to give you a bit of insight into the Government’s thinking in regard to the regulatory framework. I want you to look not at just what you need to do but why you want to do it.
Complementary medicine is a growing industry. Its use is already widespread and is increasing across the developed world. Australians are spending more out of their own pockets on complementary and alternative medicines than they do on prescription medicines.
Two-thirds of the adult population are using at least one product and one-quarter use complementary medicine services. Conservatively, spending on these services adds up to $2 billion annually.
The use and effectiveness of complementary and alternative medicines and practices provides a point of polarity for both the public and health care profession.
Some people trust alternative treatments over traditional Western medicine. Some medical practitioners appreciate the role that complementary medicines can play in our overall health.
On the other hand there are people who have tried alternative treatments unsuccessfully, and medical practitioners who regard complementary medicine as unproven.
Our Government recognises that many Australians value alternative health treatments and products, and that we must work with industry to investigate the benefits, especially with the growing health challenges posed by chronic diseases such as diabetes, arthritis, mental health problems, obesity and heart disease. We must also clearly understand that like all medicines and treatments there are potential risks.
The regulatory framework provides a tangible benefit to your industry. It allows you to proceed with confidence in the development of products – you know what is expected and you know how it is assessed.
But more than that, it also provides your market – the people of Australia – with confidence that your products meet the standards one should expect in a world-class health system.
The regulatory framework is not static nor is it subject to continual change for change sake. The Government’s aim must always be to ensure the safety and wellbeing of the consumer. That is my number one priority and I make no apologies for it.
But in doing this we must also support industry so that you can confidently contribute to our health system.
We are implementing a number of long-overdue reforms to reduce regulatory burden, increase transparency and access to information, and enhance post-market monitoring. In brief:
- We are improving access to information and improving the transparency of the TGA regulatory processes. This includes expanding the range of publicly available information about therapeutic goods on the Australian Register of Therapeutic Goods.
- We are ensuring all TGA external committees have consumer representation and improving the committees’ efficiency and transparency.
- We are working to improve where necessary the quality standards for the ingredients in complementary medicines.
- And we are establishing a statutory expert advisory committee to advise on the safety of medicines. This will replace the existing Adverse Drug Reaction Advisory Committee.
- We are also looking at other areas needing reform – things like advertising; the complaints process; and scheduling. There is more work needed in these critical areas.
You want good products in the market because good products sell and create demand for other good products. You want your consumers to be informed about the benefits of your products, and alert to any risks. You want confident consumers who will champion your products.
There is no greater tool at our disposal than the TGA regulatory framework to help us build the confidence that consumers and industry need.
An important element of this confidence for consumers is confidence that the claims made for complementary medicines are realistic, and that their health professionals can provide well-informed advice on these products.
Recent National Prescribing Service research showed that one of the factors stopping our medical professionals from openly discussing complementary medicines with their patients is a lack of information – they don’t know enough to hold informed discussions. It also showed that they want to know more about potential reactions. There is a great opportunity for you to build their knowledge and confidence through your marketing and information activities. It also showed that consumers want their GPs to give them information about complementary and alternative medicines.
But having said that, we need to be careful that creative thinkers in marketing departments do not stretch the boundaries of the evidence, or the law, for the sake of market penetration or impact. I know you would agree with me that raising false expectations in the minds of vulnerable or desperate consumers is totally unacceptable.
Australia's current system for regulating the advertising of therapeutic goods is based on a model of co-regulation in which the government and other parties, including the complementary medicines sector, all play important roles. The co-regulatory model was incorporated into the national regulatory framework for therapeutic goods in 1996.
Most of you will be aware that the key components of the current system include the Therapeutic Goods Advertising Code, the TGAC Council, an advertising pre-approval scheme for advertisements intended for publication or broadcast in the mainstream print and electronic media and the Complaints Resolution Panel.
However, there is now general agreement amongst those who deal with the current system that it is not working as well as it could. Criticism has come from sections within industry, from health professionals, and from consumer groups.
It is important that there is a robust and effective system for regulating advertising, as this will provide confidence for consumers and for you. For consumers, it’s about knowing that the claims they read and hear are well-founded. For you, it’s about ensuring an honest and level playing field.
I should add that the processes for dealing with complaints should be as much designed to protect you – those doing the right thing – as to protect consumers.
I believe it is now time for us to look at a new approach to advertising therapeutic goods that is simpler for consumers to understand and industry to implement, more consistent across sectors and removes unnecessary costs and delays.
In particular, I am aware that the complaints handling and review processes have become overloaded. Complaints are not resolved quickly, and as a result corrective action, such as retractions do not have the impact they should.
I also believe that there is a need to strengthen the sanctions and penalty regime to deter inappropriate advertising.
Pre-approval is required for main stream advertising but not internet advertising and in an environment where revenue from internet advertising will shortly overtake revenue from mainstream media advertising, I am not sure that pre-approval for mainstream media and not internet advertising is very logical.
In moving towards a new approach we need to take account of the strong regulatory framework environment in which these goods are brought to market, and the conditions imposed on them to maintain their quality and safety.
In the coming months the Government intends to release a consultation paper on improving the advertising arrangements for therapeutic goods. It will focus on reducing regulation where possible, while maintaining appropriate protection of public health.
This conference will help you stay in touch with what’s going on in your industry, particularly international developments in pharmacovigilance. This knowledge may help you contribute to improving our own framework.
I encourage all of you to use this opportunity to build awareness of drug and herb interactions and build your understanding and reporting of adverse drug reactions and contra indications. This is critical. You must actively look for information relating to adverse reactions with complementary medicines. As more Australians turn to complementary medicines we need to ensure that they are safe and used appropriately with other medicines.
This conference is another way in which we are building confidence in complementary medicines. I hope you get a lot from it and I wish you good health.
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