A-Z Index | Contact the Department | Search Advanced Search

Home > Ministers > The Hon Catherine King MP, Parliamentary Secretary for Health and Ageing > Media Hub > Opening Complementary Medicines Industry Leaders’ Parliamentary Reception - Parliament House, Canberra

View by date:

• April
  • January
  • February
  • March
  • April
  • May
  • June
  • July
  • August
  • September
  • October
  • November
  • December

• 2013
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • 2008
  • 2007
  • 2006
  • 2005
  • 2004

Previous Ministers

PDF printable version of Opening Complementary Medicines Industry Leaders’ Parliamentary Reception - Parliament House, Canberra (PDF 104 KB)

20 March 2012

I would like to begin by acknowledging the traditional owners of the land on which we are meeting, and pay my respects to their Elders, both past and present.

I am pleased to welcome you to Parliament House, and to the 2012 Parliamentary Reception for Complementary Medicines Industry Leaders.

I am glad to see so many industry leaders from your sector in Parliament today.

Can I also acknowledge my colleagues the Minister for Health, Tanya Plibersek, the Chief Government Whip, Joel Fitzgibbon, Senator Claire Moore, the Hon Bronwyn Bishop and a number of other MPs and Senators.

It is some months since I last had the opportunity to address you all collectively, and there have been, as you know, some key developments in the TGA during that time.

In December last year I announced the Blueprint – the Government’s TGA reform package.

After many months, and many reviews (over 50 recommendations touching upon nearly every element of TGA’s work) the Government has now set in place our vision for the future of Australia’s therapeutics regulatory body.

The task now is to implement the reforms we’ve announced, and to do so in a collaborative and constructive fashion.

We have an ambitious program of work ahead of us and I am committed to ensuring that this work results in an improved agency that better reflects community expectations while also better serving the industry it regulates.

The reforms are designed to improve the public understanding of the TGA and its processes, and in doing so increase trust in both the regulator and the regulated products.

Complementary medicines regulation balances a number of objectives. Of course, the TGA’s primary responsibility across therapeutics is to protect public health and safety.

For your products, this is balanced by ensuring access for consumers to complementary medicines products, and maintaining a low regulatory burden for industry, based on the lower risk of complementary medicines.

As I discussed the last time I addressed CHC members – at your conference last year – concerns have been raised over recent years about the levels of non-compliance with the regulatory requirements by some complementary medicines sponsors.

In response to this, the TGA established an informal working group with members of your industry as well as other stakeholders, to provide options for government consideration, which would seek to identify both why the level of non-compliance was at the level it was, and how that might be rectified.

The Auditor-General also conducted his review into the regulation of complementary medicines.

The recommendations of both these investigations have been considered and are responded to through the Blueprint.

It was identified that a large proportion of the compliance issues were as a result of a lack of clarity relating to the requirements.

In response, the Government has announced that the ‘Guidelines for the levels and kinds of evidence to support indications and claims’ will be updated and included in the regulations.

Further, the Electronic Listing Facility, by which complementary medicines are included on the Australian Register for Therapeutic Goods, and therefore available on the Australian market, will be amended so that the user receives greater information relating to the requirements, as well as the potential consequences of providing misleading or unsubstantiated claims.

It was my view that providing this extra information to sponsors about the current regulatory requirements was preferable to changing the regulations, and I look forward to their implementation and your feedback on their success.

In order to maintain the current regulations, but provide extra incentive to those sponsors who have not quite been at the level we require, I have also asked the TGA to look at enhancing the sanctions and penalties associated with repeated breaches.

A regulatory impact assessment will be conducted by the TGA on this proposal.

The Government is committed to providing Australian health consumers with clear and accessible information about the healthcare products they choose.

Large proportions of the sector, in particular community organisations, have called for changes to the labelling of complementary medicines, including clear explanation of the ‘AUST L’ number on these products.

It is the Government’s view that greater explanation of the regulatory arrangements for complementary medicines, including this labelling change will enhance public faith in the regulator and be a positive step towards greater transparency.

As such, the TGA, in consultation with stakeholders, will investigate options to amend labelling of complementary medicine products.

Of course, there is work to do to identify the best options to achieve this, and I hope to do that through positive and constructive collaboration with your sector as well as the range of TGA’s stakeholders.

Increased compliance will reduce the criticism levelled at your industry and improve trust.

To ensure that the Blueprint reforms are delivered in a timely and logical sequence I have undertaken to publish an implementation plan in the first half of this year.

The implementation plan will reflect that the Blueprint is a major undertaking and will be spread over several years, in three phases:

• an initial phase designed to improve communication
• a second phase which will focus on improved practice
• and finally, a period of measuring and reviewing sustainable practice.

Collaboration is a key element of the Government’s approach to implementing these reforms.

Collaboration will ensure that the reforms successfully set TGA on a stronger footing with all stakeholders.

Seeking and listening to stakeholder viewpoints through the various reviews of the TGA was critical to the development of the Blueprint for a more effective regulatory system for medicines and medical devices in Australia.

I now seek your engagement in their implementation.

As an initial key element of the reforms, to be actioned at the outset, I have asked the TGA to establish the Australian Therapeutic Goods Advisory Council whose membership will be representative of the TGA stakeholder base.

The Council will oversight the implementation and evaluation of all the recommendations resulting from the transparency review.

There is a strong focus on the TGA improving its communication and engagement and it will be working with stakeholders to develop consultation principles that deliver transparent engagement in regulatory policy making on emerging issues, and to promote accountability to the public.

There will be several opportunities for industry input during this phase of the Blueprint, and again I encourage you to take the opportunities that will be available to you to get involved in shaping regulatory change in Australia.

Regulatory and Cost Recovery impact assessment, as well as amendments to the regulations will be required in a number of cases.

These last two years have seen much activity in Australia’s regulatory space for therapeutic goods.

2012 is proving just as busy as the Government moves to begin the process of reforming the TGA.

The Australian Government realises the importance of the complementary medicines industry to Australians, to our economy, and to the growing numbers of Australians who choose complementary medicines for their health and wellbeing.

We believe that a regulatory system that is clearer and more responsive to the changing needs of those who rely on therapeutic goods is an important element of a healthy society.

Collectively, the Blueprint reforms will enhance the regulatory framework, and ensure that it remains adaptable to community and industry expectations.

As a result, we will continue to work together to achieve better health outcomes for all Australians.

Thank you for giving me the opportunity to address you this evening, it is with great pleasure that I open the Complementary Medicines Industry Leaders’ Parliamentary Reception, I hope you have an enjoyable evening.

Ends