Title The Annual General Meeting of the Complementary Healthcare Council, Melbourne, Wednesday 1 March 2000: speech.
Database Press Releases
Date 01-03-2000
Source PARLIAMENTARY SECRETARY - HEALTH AND AGED CARE
Author TAMBLING, Grant
Citation Id GKZ06
Cover date Wednesday, 1 March 2000
Format Online Text
In Government no
Item Online Text: 454427
Key item No
MP no
Pages 6
Party LPA
Speech Yes
System Id media/pressrel/GKZ06


The Annual General Meeting of the Complementary Healthcare Council, Melbourne, Wednesday 1 March 2000: speech.

Speech Grant Tambling Parliamentary Secretary for The Minister for Health and Aged Care

THE ANNUAL GENERAL MEETING OF THE COMPLEMENTARY HEALTHCARE COUNCIL MELBOURNE, WEDNESDAY 1 MARCH 2000

Distinguished guests, Complementary Healthcare Council Office Bearers, Affilliated members, Ladies and Gentlemen - Thank you for the opportunity to share with you the occasion of your first AGM and Conference as the Complementary Healthcare Council.

At your launch in Sydney, what seems just a short time ago, I remember wishing you all the very best as you began your life as a strong new representative body.

I also recall looking forward to working together with you at meeting the challenges which we then faced in seeing complementary healthcare products take their place within the range of healthcare options available to Australians as they increasingly take responsibility for their own health and well being.

I have certainly witnessed significant progress in the complementary healthcare field over the past year. I have enjoyed and appreciated the way the Council has taken up issues of importance to all of you with Government. Members of the executive have kept us on our toes, and, at the same time worked with Government in refining and implementing the range of measures we introduced to help industry and its products gain greater recognition and move towards achieving its proper place on the healthcare scene.

Just to recap and take a moment to remind ourselves of some of the things we have achieved over the past year or so. I appreciate some of you here today may not have been present during the important formative period through which the current regulatory framework for complementary medicines has been developed.

Just on a year ago the Federal Parliament passed a Bill which represented the first component of a package of reforms designed to provide a new and appropriate framework for the regulation and management of complementary medicines.

In setting up the regulatory framework flowing from the Bill, the Government promised that public health and safety would not be compromised - but we also wanted to ensure that the healthcare industry is not weighed down by unnecessary or lengthy approval processes which might put Australia at a competitive disadvantage with the rest of the world or which would deny consumers timely access to products.

The reform package saw changes to the Therapeutic Goods Act which:

provided greater clarity and certainty in relation to the application of the legislation, especially in regard to the food/medicine interface; ●

The changes also acknowledged the shift of focus from market entry controls to post market vigilance for low-risk 'listable' goods; ●

And they established the existing Complementary Medicines Evaluation Committee, or 'CMEC' as it is known, as a statutory committee. ●

A range of administrative reforms were also introduced - aimed at improving the management of complementary medicines and ensuring the involvement of industry and consumers in policy making.

The Office of Complementary Medicines was established within the Therapeutic Goods Administration and this, I think, was a major landmark in the overall recognition of the role complementary healthcare products can play in the maintenance or improvement of health and wellbeing, and of the commensurate need for appropriate administrative arrangements for their regulation.

Many of you have day to day contact with the Office, particularly Val Johanson and her team, and I am told this has greatly assisted the work of both the Council and the Office as many of the issues which have arisen are able to be constructively worked through.

We also established the Complementary Healthcare Consultative Forum on which you are ably represented by Euan and Marcus - both of whom give a strong account for your industry. The Forum, which has a good sprinkling of industry, practitioner, research, consumer and government representatives and has, after only two meetings, made important contributions to debates on issues of critical interest to the complementary healthcare sector. Perhaps the most important achievement, in terms of the future of your industry, is:

research and development in complementary medicines. The Forum has been instrumental in seeing the 'in principle' agreement by Government for the establishment of a $2 million fund to be administered over 3 years, where the government will match industry contributions to the fund on a dollar-for-dollar basis. I personally want to see Australia move towards being a centre of excellence in such research. We will soon sit down to work out how to put in place such a funding arrangement as well how to identify possible priority areas for research. I think you should see this development, as I do, as one of the most significant of all that we have achieved over the past year or so.

The Forum has also canvassed practitioner issues and we are looking at options and models for the regulation of practitioners particularly given the incentive, by way of GST exemption, from the Federal Government to encourage certain complementary professional groups to move down the appropriate regulatory track.

On this last point, you may have noticed that in this year's Budget papers and reflecting the reform agenda, the Health portfolio has, for the first time, moved to a highly specific set of outcomes with a clear focus as to what can be achieved.

The recent review of advertising arrangements for therapeutic goods is, I know from speaking with Marcus Blackmore, the most critical issue for industry to emerge from the complementary medicines reforms and it certainly the one which has generated the most heat.

Both government and industry agree that the existing Therapeutic Goods Advertising Code was somewhat outdated and no longer meeting the needs of industry or government. This began a comprehensive review of the Code and guidelines by the Therapeutic Goods Advertising Code Council.

Many players saw this initiative as the one to deliver significant gains to the sector in that it presented an opportunity for a deregulated approach, a level playing field and, at the end, significant commercial

benefit.

The TGACC, representing all industry sectors and consumers, set up its own working party under the chairmanship of Phil Daffy who performed the dual role of chairing both the TGACC and the working party. I would like to take the opportunity to thank Phil, as outgoing chair, for taking on this momentous task, and for the even handed way he has presided over the very demanding work of the Code Council - well done Phil.

I have endorsed the review recommendations and hope to be in a position to formally launch the new Code next month, depending on the legislative program in the Parliament.

Now I am aware that some of your members have voiced serious difficulties with the process or the findings of the review and remain in some doubt about the extent of the real benefits which will be yielded from the exercise.

There is no doubt that the review will herald in some changes to the way we currently do things and that a period of adjustment is therefore in order. I think that there is a growing realisation that the review offers a new hierarchy of claims that did not exist before, and at the top end, a scheme which permits a range of high level claims, provided sponsors hold the evidence.

In conjunction with the review, CMEC developed a guide for levels of evidence to support claims and it this work which has been the cause of some anxiety for the industry. For the first time, there is an evidence-based framework for those wishing to make claims.

Now I think it is important to keep in mind the Advertising Code covers the advertising of all therapeutic goods, not just complementary medicines and that the intent of the review from the start was to stay with one Code covering all therapeutic goods. To do otherwise would lead to confusion, differing standards and a lack of certainty and predicability necessary for industry in the market place.

I encourage all players to let the new system have time to settle. It is intended to have a trial of the CMEC levels of evidence work. This will lead to further improvement and I would encourage you to participate in the trial and to make your views known.

The new Therapeutic Goods Advertising Code will offer sponsors increased opportunities to make a wider range of claims where the appropriate level of evidence is held at the time of Listing or Registration. The new Code is less prescriptive than the current one with the extensive list of prohibitions in clause 4 being replaced by a considerably shorter table of prohibited and restricted representations.

The new Code and the guidelines on levels of evidence provide a framework for a more common understanding of the basis of advertising claims. The new Code reflects current knowledge, acceptable practice and community standards. It draws on international experience and is based on a number of principles, the basic one being that both claims and advertisements should be truthful, valid and not misleading. The new Code will establish a level playing field in terms of the evidence required for claims made by any sponsor for any medicine. Transparency and consistency in this area can only assist in the longer term, building confidence and positioning the industry more firmly for the future.

Just on the CMEC guidelines themselves, I am aware a public consultation was held in Sydney last month to present the most recent progress on this work. The TGA tells me that the meeting was very constructive and the audience, which included many of you, highlighted a number of additional issues which have since been considered by CMEC and which have led to several more amendments to the document and its trial. For example, specific evidence requirements relevant to homoeopathic and

aromatherapy products have been defined.

It is important to remember that the 'levels of evidence' approach will be trialed from now until July 2000 to identify any major gaps in the new system. To ensure an orderly transition and minimise any confusion arising from the new arrangements, I have recommended the establishment of an Advisory Group that will be chaired by the TGA and include representatives from the CMEC and the Medicines Evaluation Committee (MEC).

The Advisory Group will perform two primary roles:

To provide advice [to the TGA] on whether the evidence held by sponsors for listable therapeutic claims is in accordance with the 'Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Products'.

To evaluate the trial ending July of the levels of evidence and report by 31 August 2000, using the information agreed upon by the Advisory Group, and report to the TGA.

During the trial period this will help clarify any uncertainty that may exist in relation to whether a product requires listing or registration based on the proposed claims and the evidence available to support those claims. The first meeting of the Advisory Group was on 15 February and I'm told the meetings will occur every two weeks or so to make sure sponsors will have access to timely advice during the trial.

The Advisory Group will confer closely with CMEC and MEC to ensure that the benefits of the trial are passed on and realised in any amendments to the guidelines for levels of evidence. It is important to understand that although the trial is for a finite length of time, the levels of evidence guidelines is a 'living' document and may be amended as required following recommendations to the TGA by the TGACC, CMEC or MEC.

Over the course of the advertising review, advertorials and generic information has been the most contentious issue and I have had a number of representations from the various industry players on these topics.

The fundamental issue, as I see it, is being able to establish a mechanism which protects consumers from misleading, deceptive or unbalanced material that may ultimately lead to inappropriate diagnosis or treatment, while at the same time, enabling consumers to receive useful, up to date information.

I acknowledge that some of your concerns have been that the new advertising arrangements appear to 'censor' information, but in my view, the implementation of the new arrangements should not lead to onerous restrictions - rather, they should provide an assurance to Government and to the community generally that consumers will not be mislead, that the vulnerable will not be preyed on and that (in line with the quality use of medicines) consumers will not be lead to self-diagnosis and treatment.

Following recent meetings of the TGACC we are now in a position to move forward on the 'generics' issue. I am advised that an agreement has been reached - generics will not be precleared, however, they will be subject to post-market monitoring. Furthermore, generic advertisements will be subject to the main requirements of the new advertising code including the requirements to be factual and not misleading. Added to this, generics will also be subject to complaints resolution arrangements.

I would simply urge you to give the new arrangements, which are by no means set in concrete, a chance to work and undergo the agreed review period.

The review and associated public consultations have highlighted the need for firm and timely responses where transgressions occur in the market place. The role of the complaints resolution

mechanisms, in which your Council has a key role, will be enhanced in respect to the types of advertisements able to be considered and the range of sanctions able to be requested. A number of regulatory amendments aimed at achieving this have been prepared for the completion of the advertising review and will be presented as part of the overall consolidated package.

After the new Code comes into force, sponsors will have four years to bring all currently approved advertisements for existing products into compliance with the new arrangements. This is an important point to stress. There will be some circumstances where products will have to comply with the new arrangements prior to the end of the four year period.

This includes circumstances where there is:

a public safety concern; ● an upheld advertising complaint; ● the introduction of a new product to the market place; or ● the use of a new claim for an existing product. ●

The TGA is currently reviewing the procedures relevant to implementing the new arrangements, particularly in terms of ensuring an orderly transition to the new arrangements and maintaining timely processing of applications. This will involve close consultation on listing procedures and the further development of the electronic lodgment facility which I will mention further in a moment.

I think it is crucial that sponsors be aware of the proper procedure in relation to lodging applications, and if necessary, in seeking advice from the Advisory Group and many of these issues were thrashed out at a 'round table' meeting a couple of weeks ago where some of you were in attendance.

Last but not least of the administrative reforms was a number of streamlining initiatives principal among which is the enhancement of the electronic lodgement facility or ELF. ELF is being fundamentally redesigned to enable faster and easier access for complementary medicine sponsors to the market and as a result improved access by consumers to them. Several of your members have worked closely with TGA during the design phase of this facility and I welcome your ongoing involvement to see it successfully launched toward the end of this year.

In summary, the combination of all these reforms has provided a unique opportunity to achieve a co-operative approach to health care and medicines regulation. Your Council has played a major part in guiding the Government in the development of those reforms and will continue to play an ongoing role in ensuring those reforms will have maximal positive impact for the industry and the consumers of complementary healthcare products.

The other important development which has occurred recently is the launch of the National Medicines Policy which has been under development in various forms for quite a long period. I was personally very keen to broaden the scope of the Policy's partnership and thanks to some timely and well structured input from the Council, the final revised policy was launched just before Christmas.

Where to from here for the next year?

There are a number of areas I would encourage you to focus on as immediate priorities.

First and foremost is STRATEGIC PLANNING. We have got the regulatory framework in place and most of the reforms are up and running - it is now time to begin building on the successes of the recent past and for the CHC to begin telegraphing to Government where you see yourselves in five years from now. You should be involved in the development of the TGA's strategic plans and we will certainly consult on future budget issues.

ADVERTISING - Of course we need to bed down the new advertising arrangements and the levels of evidence framework and I would encourage you all to be actively thinking as to how to make the system work for even better outcomes for the sector - I do believe the opportunity is there but it will require some further adjustments and even educative measures for your members to ensure we see our way through the trial period and beyond.

CMEC - I am encouraged to note the CMEC agendas are providing an increasing throughput of new listable substances and registrable products which you the industry have identified or developed as marketable entities. The revamped CMEC configuration now includes a healthy diversity of skills and experience and I think the Committee has now melded into an effective and cohesive unit which places a high priority on developing consistency in the regulatory recommendations it makes. I encourage you to consider how the CMEC process can be utilised to provide even better outcomes as you consider individual and grouped new substances which have market potential and which offer better health and well being options for Australian consumers and then go about the important task gathering the necessary supporting data in the form of applications to CMEC.

NEW ZEALAND - The New Zealand industry and New Zealand government are understandably paying close attention to where the reforms have taken us and I have been doing my best to ensure that I keep them up to speed on where we are up to - and I know the CHC has been doing likewise. This is of course increasingly important as we continue on a path which will see even closer and more co-operative trans Tasman relationships in the future.

POST MARKETING VILGILANCE - One of the things that will come to the fore as we move ahead with the more efficient front-end of the regulatory system is the need to ensure that we have mechanisms in place to ensure safety and quality of complementary medicines after they have found their way into the marketplace.

This will be achieved in part through better information management systems like enhancements to the ARTG and the new ELF system which will be able to assist in identifying and homing in on those products which pose the greatest degree of risk. It will also be achieved through better surveillance processes including a coherent laboratory testing regime and importantly through a fine tuning of the Adverse Drug Reaction monitoring program so that it can capture information on complementary medicines in an appropriate way. Of course much of the detail of this is still to be worked out within the TGA.

Conclusion

In closing I would like to wish you all the very best for the future - we have come a long way since we first met just over a year ago to make plans for reform measures which would see the complementary medicines industry become a significant player in the healthcare arena.

I believe we have now laid down the ground-work for this - but the road to achieving, while not always smooth, has certainly been exciting and challenging. What has been encouraging for me particularly, is the interest shown by overseas authorities in the system we have been building in Australia - elements of this have served as useful guides for other countries in modelling their own systems for regulating complementary medicines, dietary supplements and foods.

Throughout this process I have gained a greater understanding of what are the priorities and expectations of each of the players in the complementary medicine arena are. I am confident the co-operation which has characterised our progress thus far will stand us in good stead as we face the challenges the future will certainly hold.