National Herbalists Association of Australia Fourth International Conference on Phytotherapeutics

Grant Tambling, Parliamentary Secretary for the Minister for Health and Aged Care officially opens the Fourth International Conference on Phyto-therapeutics.

In this section:

Friday 23 February 2001
12.15 pm

Opening

National Herbalists Association of Australia Fourth International Conference on Phytotherapeutics

Speaking Notes

Distinguished Guests, Conference Delegates
Firstly, I want to thank the National Herbalists Association of Australia for the invitation to be here today, and to say how pleased I am to be asked to officially open this Fourth International Conference on Phyto-therapeutics.
Your events for the next two-and-a-half days promise that this will be a truly stimulating conference. It is gratifying to see an array of invited speakers of such high quality, and a conference program that captures not only the very latest information from herbal medicine research but also explores how this research can be applied in practice and to clinical settings.
It is indeed exciting to see how a vast number of herbal materials available to us from nature are being investigated for the development of new medicines and also for more effective and informed use of existing ones.
This quest for better healthcare through natural plant-based medicines is part of an international move towards complementary medicines. Interest and expertise in medicinal herbs and herbal extracts is continuing to gain momentum in Australia - and Australia is positioning itself to be an important player in this area.
The move by professionals and consumers to embrace a wider spectrum of therapeutic approaches and products is clearly being driven by a number of factors, but principal among these are:
- The need to minimise healthcare costs to consumers and, I'm happy to say, governments through better access to effective complementary, therapeutic and preventative medicines; AND
- The steadily increasing acceptance by governments, regulators, the community and the various professional groups of the benefits of having access to a diverse range of complementary healthcare products

I would also add that this trend to therapies based around complementary medicines and herbal products is due in no small part to the work being done by practitioners and researchers in examining the mechanism of action of herbal substances and their application to healthcare. To be successful in the long term, the sector must be credible and this work provides a foundation for credibility that the community understands.

[$1 million research matching funding from Government not taken up]

Of course, along with increasing expectations of consumers regarding the health benefits provided by practitioners and products, come the increasing expectations of the community for maintenance of health and safety standards.
Both of these add up to the need to find more and better products, and to apply appropriate rigour in research, development and regulation.

Challenges for Government

So, if we look specifically at the important issues confronting governments as a result of all this -

Clearly, governments have obligations to maintain optimal standards of public health and safety.
- Consumers in the healthcare system are increasingly relying on self-administered medicines, including complementary medicines, either instead of or along side conventional medicines.
- They expect and demand from governments a high degree of assurance about the safety, quality and effectiveness of all medicinal products.
- This can only come about when they have confidence in the regulatory processes at both market entry and post marketing levels.
The challenge for governments is to balance the need to improve market access for beneficial self-medication healthcare products and the need to maintain consumer confidence in appropriate regulatory standards.
Striking that balance is an ongoing challenge as many in this audience will testify.

The Australian Government's response

Just over two years ago, this Government stepped up its efforts to recognise the rapidly changing landscape for medicinal products here in Australia. Since then, major changes have been introduced to respond to these trends - complementary medicines have been at the forefront of these changes.
The review in 1998 of the regulatory arrangements for complementary medicines was pivotal in turning ripples of change into what we can now say was a watershed. The driving forces for this were:
1. The need to ensure a level of government regulation that reflected the low risk of most complementary medicines;
2. The need to be able to substantiate therapeutic or health-promoting promises made by these products; and
3. The need to ensure that once in the market place or the medicine cabinet, there were systems in place to check for any problems.

The review process

Our review had its genesis in a Working Party on Complementary Medicines. Industry was fully involved from the start in this work. The path we followed, in building the new system, was not without its difficulties as we found ourselves having to work through many important issues.
There were some vigorous debates around the need for a 'light touch' approach for what are mostly low risk products. We also had 'interesting' discussions around who should foot the bill to build the new system, given who was most likely to benefit from it. And we debated the system being a truly co-regulatory model as a way of ensuring industry and consumers were part of the regulatory process and that there were checks and balances for both Government and industry.

The review outcomes:

The important outcomes flowing from the review impacted on a number of fronts:
1. Firstly the reforms saw the establishment of the Office of Complementary Medicines within the Therapeutic Goods Administration.
  - This gave a tangible profile within the government regulator body for the industry and consumers to deal with for the first time. The Office has forged the way for conducting careful risk assessment procedures for assessing the relentless flow of new complementary medicine substances.
  - It is staffed by highly qualified and experienced personnel with an understanding of complementary healthcare products and related issues.
  - It combines the evaluation process and listing application handling for complementary medicines under one roof.
  - I am pleased to note that Michelle McLaughlin from the Office has been invited to present a paper to this conference;
2. Secondly, the body which assesses those substances, the Complementary Medicines Evaluation Committee was given recognition as a statutory Committee for the first time.
  - The NHAA President, Nick Burgess, sits on CMEC as a herbal specialist where I know his experience and wisdom are much appreciated.
  - CMEC played a pivotal role in developing the level and quality of evidence guidelines to support claims made for therapeutic goods as part of the review of advertising arrangements, which I will come back to a little later.
  - Dr Rajan Cooppan and Rob Santich, who have both contributed as members of CMEC's Expert Advisory Panel, will be presenting papers to your Conference.

One of the things of particular interest to this audience that the CMEC has been wrestling with is specific consideration of the regulation of therapeutic herbal substances in Australia. Together with the TGA, the CMEC is working to put together a consultation paper which outlines the problems that have emerged from the current system of regulation and which addresses the unique regulatory challenges posed by herbally derived therapeutic goods. One of the factors that has been a major driver for reassessment both in the industry and for regulators has been the emergence of more advanced technology which has provided purer herbal extracts and also the capacity to identify and separate active herbal components.

The consultation paper will seek input from stakeholders on mechanisms to address the issues identified, and it is anticipated that the paper will be circulated for public comment later this year.

The reform package also included a thorough review of existing advertising arrangements for medicines - and what eventuated was a new advertising Code which was less prescriptive and which focuses primarily on public safety issues.

The new Code was supported by Guidelines developed between CEMC and the TGA and outlines the type and extent of evidence required to support product claims.

The Guidelines are governed by an overriding principle that the promotion of therapeutic goods should be truthful, valid and not misleading.

The new arrangements now enable industry to make a wider range of claims without compromising public safety while consumers will continue to benefit in receiving accurate and up to date information.

As part of the new system I also established the Complementary Healthcare Consultative Forum.

This Forum allows a wide range of stakeholder groups to engage in full and frank (and I must add, very lively) discussion of the critical issues facing the sector.

Things like the place of self-medication and non-conventional therapies within the healthcare spectrum, the impact of the Internet, the regulation of complementary practitioners, the changing controls over advertising of medicines and the trend towards evidence-based support for product claims.

David McLeod, who has served the NHAA both as President and, until recently, as a member of the NHAA Board of Directors, sits on the Forum to bring his expertise as an herbal practitioner as does Assunta Hunter who is on the Peer Review Board for the NHAA's Australian Journal of Medical Herbalism.
David and Assunta are two of six complementary healthcare practitioners around the Forum table and they will be particularly interested in the activities that are happening regarding practitioner regulation.

Practitioner Regulation

Many of you will be aware of the $500 000 funding promised by the Commonwealth some time ago to assist suitably qualified practitioner groups in the areas of acupuncture, naturopathy and herbalism to maintain their current GST-free status beyond June 2003.
The development of this funding initiative followed liaison with complementary therapies associations and other stakeholders during the implementation of the GST legislation.
The Government continues to welcome input from national associations such as the NHAA.
I am pleased to advise that this funding initiative is now being implemented.
The first step in this project was the advice to the major professional groups (including NHAA) in December last year, advising them of the process to be followed.
The next step will be the call for collaborative proposals from practitioner groups. This will take place, I am advised, in the coming week, through the placement of a national advertisement and letters of invitation to all relevant professional associations.
At this stage I am informed that the process is being well received by professional associations, which are responding favourably and in a proactive fashion.
Particularly encouraging has been the contribution of the NHAA, to the process of establishing collaborative proposals. Their initiative along with other major professional bodies to form a GST Steering Committee to collaborate on the development of submissions for the three sectors covered by grants is welcomed.
In summary, the GST legislation has served as a catalyst for a welcome initiative, which will give practitioner groups the opportunity to demonstrate their professionalism through a national body and thus enhance consumer confidence at the national level.
It has given recognition to the popularity of herbalism and the recognition of the leadership role already played by groups such as the NHAA.
I am sure that establishment of an inclusive, national professional registration system will further increase the visibility of the profession. The anticipated positive outcomes of the funding will be that the practitioner groups will have a strong unified voice, a robust national registration system, and consumers will be assisted in easily finding accredited practitioners.

Herbalists Access to Scheduled Medicines

I am also aware that Australian herbalists have a strong interest in being able to access and prescribe certain herbs which are currently off-limits because they are included in one or other of the Drugs and Poisons schedules.
Of course, the development of appropriate standards of professional accreditation for practitioners would seem to be logical pre-requisite in order to make strong case for access to a wider range of substances for use in herbal practice. The opportunities that recognised accreditation standards might bring for considering other professional matters such as this - and not just for GST reasons - underline why it is important that progress be made on practitioner registration.
I have noted with great interest the recent steps in Victoria regarding recognition of Traditional Chinese Medicine practitioners and access to scheduled substances. This may serve as a useful model for other practitioner groups such as herbalists to follow. I would encourage the NHAA to learn from the experience in Victoria in developing its position.
Other areas where we have been able to make progress with either legislative or administrative changes is in clarifying definitions for complementary medicines and food, and in streamlining electronic lodgement for listing complementary medicines and herbal products on the Register.
It has taken the work of many but the changes I have outlined are helping Australia to establishing itself as one of the world leaders in the regulation of complementary healthcare products and as an innovator regarding supply and use of herbal medicines generally.
The Australian regulatory framework assists in maintaining the high quality and safety of the self medication products coming from our very active and innovative industry - a factor which already has a significant and positive impact on the way those products are viewed in the rapidly changing markets both in opportunities in Australia and overseas.
I have no doubt the Australian experience will serve as a useful model for others and has established us as a world leader in the regulation of complementary healthcare products.
A Conference such as this provides an opportunity to take stock - build on the strengths - and look forward once again.
Which brings me back to the Conference itself - the line up of local and international speakers and the array of topics suggests a program of very high quality and covering broad range of interests.
I can say that as a Northern Territorian, I have had a long-standing personal interest in the traditional healing practices and traditional medicines used by Australia's indigenous communities. I have had opportunities to see some of these practices first-hand - long before I came to my current position in the health portfolio. Time-honoured traditions of using local plant materials for meeting therapeutic as well as nutritional needs have formed the basis of traditional medicine in many countries and cultures.
What we know as herbal medicine owes much to these beginnings and we still have so much to learn from these traditions. I see that a number of papers at the Conference will be addressing this.
When I was first appointed to his position, I was certainly pleased to find that my area of the health portfolio encompasses traditional and complementary medicines. I saw that there was a tremendous opportunity to recognise the role of these products.
I think there has been good progress made and it hasn't finished yet.
I am encouraged by the enthusiasm of those involved to move forward and make use of the benefits the reforms have delivered. I know there are those who will continue to challenge and push at the boundaries of the new system - that is inevitable. But we must get it right. If the opportunities are to be realised - we must work together to strike a balance of innovation and standards that are credible and sustainable.
So, it remains for me to wish everyone - delegates, speakers, and organisers - the very best for a successful, thought-provoking and enjoyable Conference.
Thank you again for your invitation to be a part of it -
I now have much pleasure in declaring "open" the Fourth International Conference on Phytotherapeutics.

Thank you

Media Contact:
Melissa Baldwin at Senator Tambling's office - 08 8981 3567