Opening of the Complementary Healthcare Council of Australia’s National Industry Conference 27 October 2011, Manly
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27 October 2011
Good morning ladies and gentlemen, I would like to begin by acknowledging the traditional custodians of the land on which we gather and pay my respects to their Elders, both past and present.
Thank you for inviting me here today to launch the Complementary Healthcare Council of Australia’s (CHC’s) National Industry Conference.
It is a great pleasure to be here with scientists, researchers and leaders from your industry.
The theme for your conference, For Australia’s Health – 2020, is one the Australian Government shares with you.
A significant part of our health reform program is aimed at enhancing the role of our preventative health as well as primary healthcare systems.
With about 70 per cent of adult Australians using complementary medicines every day we are aware of the major role you can play.
But with this role also comes some responsibilities.
Responsibilities on the part of the government to ensure that the regulatory regime for complementary medicines continues to strike the balance between safety and quality whilst not stifling innovation.
Responsibilities of the part of consumers to understand and make informed choices about the products they use.
And responsibilities on the part of industry to deliver safe and effective products that contribute to positive health outcomes within the existing regulatory framework.
As you are aware, the TGA's Office of Complementary Medicines evaluates new ingredients for use in listed medicines and in registered complementary medicines.
The TGA's Electronic Listing Facility for listing medicines on the Australian Register of Therapeutic Goods (the ARTG) was at the time of its introduction the first of its kind anywhere in the world.
The government is proud of Australia’s regulatory arrangements for complementary medicines, which are intended to protect public health while not over burdening your industry with unnecessary red-tape.
There are though, as you will all be aware, calls for improvement.
As you know, the Auditor General published its report on the performance audit of TGA’s regulation of complementary medicines in August this year.
During the review the audit team consulted widely, including with the CHC and other industry players.
The report documented recent poor compliance rates – and while much poor compliance was at what I would see as at the lesser end of the scale – there were some more concerning cases, around safety and evidence for efficacy claims.
The ANAO report’s recommendations are focussed on improving the process for the regulation of complementary medicines and the handling of advertising complaints.
In addition, the report looked at the need for greater transparency and the use of evidence and risk to manage the regulatory program.
That report made a number of specific recommendations, all of which were accepted by the TGA.
It made a number of specific recommendations, all of which have been accepted by the TGA.
These include the timely completion by TGA of key guidance material for complementary medicines.
Improving the integrity of the self-assessment process for listing complementary medicines by limiting the use of inappropriate claims and indications.
Making information available to the public on each listed complementary medicines.
Improving the quality of the regulatory framework through the use of risk profiles and
The development of documented procedures for the handling of advertising complaints, including timelines for completing investigations.
You will also be aware that earlier this year the TGA established an informal working group in response to community concerns and criticisms of the high rate of non-compliance with regulatory requirements.
Members of that informal working group included representatives of consumer groups, industry, academia and professional organisations associated with both prescription and complementary healthcare, and I would like to thank those of you present here who were involved in that process.
The informal working group examined regulatory arrangements for complementary medicines and the reasons behind the higher than expected rate of non-compliance, and identified two broad areas for improvement.
Firstly, a lack of clarity in the complementary medicines regulatory framework has meant that some in industry are not clear about what is required of them; and at the other end of the spectrum that there is public perception that the TGA has a higher level of regulation of complementary medicines than it actually does.
And secondly it was felt that the current system does not sufficiently encourage compliance, resulting in many well regarded companies, who have worked responsibly in this space for a long period, being unfairly tarnished by the few who are non-compliant.
I am grateful to the informal working group for identifying a range of possible initiatives for reform which will require some limited alterations to the system, while encouraging greater education programs for stakeholders.
I am currently giving consideration to these options, and am doing so in the context of broader reviews which have also been undertaken over the last year into a number of aspects of the TGA’s work.
As you know, and as many of you will have been involved with, reviews of TGA’s transparency; of the arrangements for advertising therapeutics; and of the promotion of therapeutic products to healthcare practitioners have all been recently concluded.
These reviews are now being considered together across government and I will soon have more to say on the government’s response to all of these important reviews.
As I mentioned at the outset, it is estimated that 70 percent of Australians take complementary medicines each day.
The significance of that is not lost to me or the government, nor is the fact that this is a $1.9 billion industry that contributes significantly to the broader economy.
You employ 5,000 Australians in highly-skilled manufacturing jobs and around 60,000 others rely on you indirectly.
You export your products to more than 20 countries around the world.
You are an important part of our economy.
Australian consumers' increasing use of complementary medicines is a reflection of the faith they place in your products and in your brands to improve health and wellbeing.
It is also a reflection on the light touch regulatory regime that exists in Australia for complementary medicines.
I am committed to improving that regulatory regime, which I believe is in the interests of both industry and consumers.
I now have great pleasure in declaring the Complementary Healthcare Council of Australia’s National Industry Conference open.
Thank you.
Ends
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