Opening Address - Consumers' Health Forum Parliament House, Canberra 29 August 2011
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29 August 2011
I would like to begin by acknowledging the traditional custodians of the land on which we are meeting and I pay respect to the elders of their people, past and present.
Thank you for inviting me to open this meeting of the Consumers’ Health Forum.
This is a very exciting time for health consumers.
Broadly, the national health reforms that this government is driving are improving the care that patients receive across all sectors of the health system, and all areas of the country.
On 1 July the government announced that it’s $416.8 million program to establish a nationwide network of primary health care organisations – Medicare Locals, was up and running.
Medicare Locals will improve the delivery of primary care service at a local level and improve patient’s access to after-hours primary care.
This forms a key component of the government’s reform agenda.
Just last week, the Prime Minister along with Minister Roxon and the Minister for Regional Australia, Simon Crean, announced the next round of the governments health and hospitals fund, which will see $475 million invested in regional hospitals around Australia.
The funds will provide patients with better care and access to health services, and complement the $4.5 billion that is already being spent on health and hospitals projects around Australia.
All these reforms are designed to ensure that health consumers throughout Australia can access the best quality of care possible.
Consumers will also be able to help shape the care they receive, with the opportunity to assist in planning and managing their local health services, through the Medicare Locals and the Local Hospital Networks, run by the states and territories.
Consumer involvement will help to ensure that the health system becomes, and remains, focussed on patient outcomes.
I am very pleased to be a member of the dynamic government which is making these long overdue reforms to our health system.
Therapeutic Goods Administration
Today I want to particularly focus on the Therapeutic Goods Administration, within my own portfolio, which plays a very important role in safeguarding health consumers.
As you know, the Prime Minister Julia Gillard and the New Zealand Prime Minister have announced that the joint trans Tasman scheme for regulating therapeutic products, the Australia New Zealand Therapeutic Products Agency (ANZTPA), will be established in a staged process over the coming 5 years.
Stage one of ANZTPA began in July, when both countries’ regulators, our TGA and New Zealand’s Medsafe, began sharing resources, expertise and information.
Soon, a Transition Agency will be established charged with analysing and working through the non-regulatory matters required to establish ANZTPA.
The second stage of the ANZTPA process will see the development of a single entry point for therapeutic goods regulation and a common trans-tasman regulatory framework agreed upon.
During the first two stages, the independent agencies in each country will continue to regulate therapeutic goods separately.
Within five years, following a review of progress and final confirmation of arrangements, the separate national regulators will be absorbed into a new joint agency – ANZTPA.
The new, shared regulatory framework will be world class.
It will mean better protection for consumers, reduced costs for industry and greater efficiency for governments.
As you will be aware, New Zealand is introducing its own separate Natural Health Products legislation to regulate low risk complementary medicines, which will therefore not form part of the initial ANZTPA arrangements.
New Zealand will review this new complementary medicines scheme in five years’ time, with the option of it being replaced by ANZTPA regulation.
I must emphasise that until a common regulatory framework is agreed, all therapeutic goods being supplied in Australian will still be required to meet Australian standards, and there will be no diminution of our own high standards.
Moreover, the trans Tasman announcement will not in any way cut across the reforms and reviews relating to the TGA which are currently underway.
While New Zealand takes this separate path for complementary medicines regulation, the Australian Government will be pursuing improvements to our own regulatory framework for these products.
The government is aware of criticism around the regulation of complementary medicines and the rates of non-compliance with the regulatory requirements.
It is clear that the regulatory framework for complementary medicines is complex and lacks some transparency.
It was my feeling that more information was required around the reasons for the non-compliance to identify what can and should be done to improve this.
As a result I asked the TGA to undertake some investigation to identify weaknesses.
The TGA convened a working group made up of consumer, health professional and industry representatives to identify concerns and highlight possible options for improvements for complementary medicines regulation and compliance.
Transparency and advertising reviews
Of course, there are two other current reviews of TGA processes.
The broad review of the TGA’s transparency chaired by Professor Dennis Pearce; and the review of the regulation of advertising for listed therapeutic products.
The Government believes that Australians should be able to easily obtain clear, tailored information about their therapeutic goods.
Consultation with CHF and other consumers has resulted in some positive moves in recent years.
Detailed product Information on prescription medicines is now published on the TGA website.
Whenever TGA decides to approve or reject an application for approval of new prescription medicines, it must now publish online its assessment report.
And the relevant legislation has been changed to allow more information to come out of the TGA’s expert committees.
These are all positive steps towards greater transparency, but as you know, I decided on coming into my new role as Parliamentary Secretary last year, that a broader examination of the TGA’s transparency was required.
Professor Dennis Pearce - a former Commonwealth Ombudsman among many other notable appointments - has undertaken a comprehensive review of the way that TGA communicates its regulatory processes and decisions.
I felt it was paramount that the review have input from a representative cross-section of interested parties, and appointed a review panel made up of consumers, health professionals and the therapeutic goods industry.
The review received 108 submissions, and the panel held public hearings in Sydney, Melbourne and Perth.
Professor Pearce presented the report to me last month and I released it publically on 20 July.
Concurrently, the review of regulation of advertising of therapeutic goods has been on going this year which I know is also of keen interest for consumers and for the CHF.
The review got under way mid last year, under the former Parliamentary Secretary, my predecessor Mark Butler.
I held a roundtable with stakeholders to gauge the views and positions, and submissions were received and reviewed.
It was clear from both the roundtable and the submissions that there are significantly divergent views from industry and consumers on the areas of concern and need for reform in this vexed area of regulation.
All three reviews, into advertising, transparency and complementary medicines regulation have involved significant work both by the TGA and by stakeholders, and I would like to thank CHF for your input and assistance to all three.
Thanks in particular to your Chief Executive Officer, Carol Bennett who has served on the complementary medicines working group, the transparency review panel and took part in the advertising review roundtable.
Thanks too to Alison Marcus and Karen Carey for their work on complementary medicines and transparency.
The outcomes of all these reviews will be considered in detail by government and it is our intention to consider in tandem.
I know you will eagerly await the government’s responses, and I look forward to CHF’s input as we work towards progressing any reforms.
As you can see from this brief rundown, this is an interesting time for therapeutics regulation in Australia.
Moving towards trans-Tasman cooperation and progressing our domestic work will require significant work and commitment from all parties.
The government, or course, recognises the very valuable contribution that consumers can make to improvements both in the TGA and in the broader health system, and their valid right to expect accurate and timely information about how the systems are working for their benefit.
Thank you again for the opportunity to open your consumers workshop, I wish you a very productive meeting.
Ends
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