Pandemonium

Government Health Policy and Complementary Medicines

By Marcus C. Blackmore AM, Chairman Blackmores Ltd.

"Government health policy should ensure public access to complementary medicines that are safe, efficacious and of high quality while respecting freedom of choice and philosophical and cultural diversity"


The purpose of this document is to facilitate informed debate on the development of government health policy as it applies to complementary medicine. There are three separate components to this document.


1. A Political Imperative

A summary of the major issues surrounding the
regulation of complementary medicines in Australia.


2. What Should Government Do?

Summary recommendations on what initiatives government might undertake to address industry and consumer concerns.


3. A Response to the Report of the Expert

Committee on Complementary Medicine in the Health System

An initial industry perspective on the Report of the Expert Committee on Complementary Medicines in the Health System, highlighting industry concerns and noting the positive outcomes.


A Political Imperative


Introduction
Michael Wooldridge was not the first Health Minister to observe that his portfolio responsibility was one more of disease than of health. What is surely required from Government is a totally new approach to health-care policy which promotes self-reliance and shifts the emphasis from a pharmaceutical drug-based government subsidised disease model to a wellness model where individuals accept greater responsibility for their own health. The responsible use of
complementary medicines underpinned by appropriate regulations, is a vital element of that self-reliance.

From the political perspective there needs to be a balance between consumer freedom of choice with respect to complementary medicines and the assurance of appropriate levels of public safety, quality and efficacy. It really is a question of informed access for the public who choose to use complementary medicines and who are no impost on the public purse.

The Pan Pharmaceuticals crisis has been a disaster for consumers and patients who use complementary medicines, and concerns have been raised about both industry and the regulator. A calm and considered approach to these concerns is vital as we lead up to the next election.

Costs of Healthcare

It is paradoxical that at a time when the intellectual debate in our society looks for answers to the spiralling costs of public healthcare, the one industry that could help government to reduce these costs has been devastated.

Historically, the Government’s health strategy, driven no doubt by political imperative, has tended to focus on the treatment of disease and not so much on health optimisation. Central to the Government’s “Healthcare reform” are Medicare, Public Hospitals and the PBS, all heavily subsidised disease care systems that may delay the onset of death from disease but do not create a healthier Australian society. There is of course greater political capital in the immediacy of cancer and heart disease treatments than simply helping us all to live longer.

Our maximum life span potential (ie, how long can we live) of some 120 years has not changed since homo sapiens appeared on the earth. Our life expectancy (ie, how long do we live) is then a function of the absence of disease, and despite modern medicine’s significant advancements in the control of infectious diseases and infant mortality, life expectancy has only improved marginally from the three score years and ten when the Bible was written, to today’s figure of some 78 years. The fact is that 85% of all health related deaths are now attributable to chronic disease.

There is a growing body of evidence that herbal, vitamin, and mineral supplements can reduce the incidence of chronic disease in fact, some of this evidence is so compelling that researchers from Harvard Medical School, after having reviewed 152 published studies over 40 years, recommended in July 2002 that it would be prudent to take a multivitamin pill daily.

In 1997, a U.S. study by Bendich noted that nearly $20 billion in hospital charges were potentially avoidable with daily use of folic acid and zinc containing multivitamins by all women of childbearing age and daily Vitamin E supplementation for those over 50. The report suggested that vitamin supplementation would be a very interesting procedure for reducing morbidity and mortality. This year, another US study by a national healthcare consulting company, The Lewin Group, determined that increased daily intake of a multivitamin by older adults could save Medicare US$1.6 billion over five years. This kind of pharmaco-economic analysis in the Australian health context needs to be given a high priority by Government.

Under the existing system an escalating $5 billion of taxpayers’ money is used to subsidise prescription drugs, whereas complementary medicines are paid for out of consumers’ after tax dollars and a whopping $130 million goes to Government coffers in the way of the discriminatory Goods and Services Tax. The ultimate irony is that the very people who choose to look after their own health are the ones that Government selectively taxes.

A New Regulatory Regime

Complementary Medicines are not drugs yet they are effectively regulated as drugs in Australia. As a direct result of widespread public protest, the Canadian Government appointed a Standing Committee on Health to review and make recommendations for the regulation of natural health products in Canada. As a guiding principle, the Committee said that “Natural health products are
different in nature from, and must not be treated strictly as either food or pharmaceutical products”. A further guiding principle agreed by the Committee was that “Natural health product regulations must not unduly restrict access by consumers”. The various recommendations of this Committee gave rise to the establishment of a new regulatory authority called the Directorate of Natural Health Products.

The peak industry body in Australia, the Complementary Healthcare Council (CHC) has argued for some years, that given the unique nature and intrinsic safety of complementary medicines, that a new regulatory authority should be established within the Health portfolio. In light of public concerns over the Pan crisis, in no way should this be considered a softening of the current regulatory environment, it would simply mean more appropriate regulation by a more appropriately qualified regulator, separate from the inherent bias of the existing pharma model of the TGA. The current Office of Complementary Medicine within the TGA is stifled by the pharma mindset of the regulator.


What Industry has proposed is a joint Trans Tasman Natural Health Products Authority with the express interest of ensuring public access to natural health products that are safe, efficacious and of high quality while respecting freedom of choice and philosophical and cultural diversity.

Quite simply, the public regards complementary healthcare as integral to general health care.

Consumers would benefit from having more information available to make informed decisions and the regulatory pre-market approvals would increase consumer confidence in safety and efficacy of natural health products resulting in a possible increase in consumer self medication with a decrease in medical problems and associated costs. The medical insurance industry already targets this type of consumer as they make fewer claims on private health insurance, however the previous Minister, Kay Patterson, has sought to remove payments for alternative therapies.

In developing such a system, the Australian and New Zealand Governments would be responsible to their constituents’ concerns about natural health products and would be seen as maintaining the Governments’ mandate to protect public health and safety in an appropriate manner. From a political perspective, there has been far too much history of public outcry as a result of past attempts by both the Australian and New Zealand Governments to regulate natural health products within a pharmaceutical drug based model.

Is Current Legislation Adequate?

Complementary medicines are regulated as drugs in Australia, unlike most other Western countries where they are regulated as foods. The current problems lie not with the law itself, but with the application of the law.

Over the past 10 years, the Australian regulator (TGA) in consultation with industry has put in place a complex system that generally serves the public well. Of course, it can always be improved. No doubt in the aftermath of the Pan debacle, questions will be raised about the nature and timing of the recalls and of the audit process, however, the existing system of regulation is adequate for public safety and is one of the strictest systems applied anywhere in the world. What we saw in the Pan incident was the system working, and the regulator and industry should not be held responsible for the actions of one particular company.

In no way do I wish to support any manufacturer that does not abide by the Code of Good Manufacturing Practice (GMP) imposed on complementary medicines, however, to use the Pan debacle to infer complementary medicines are not safe or efficacious is a gross and irresponsible distortion of the facts. The Pan complementary medicines were recalled because of the TGA’s genuine concern about manufacturing practices, not adverse reactions reported by the public.
The legislation is more than adequate, it just needs to be administered by a new authority bereft of the pharma mindset of the TGA.

How does Government Regulate Quality, Safety and Efficacy

There are three important elements for government to create a balance between consumer freedom of choice and assuring the public that there are appropriate levels of quality, public safety and standards of efficacy in place.

(a) Manufacturing Standards Underpin QUALITY

Manufacturing Standards are achieved through the application of the international GMP (Code of Good Manufacturing Practice). Few countries in the world require this strict pharmaceutical standard to be applied to the manufacture of complementary medicines, however, the complementary medicines industry in Australia has always supported such a standard. It was the alleged contravention of this standard that gave rise to the suspension of Pan Pharmaceuticals’ licence by the regulator. All manufacturers of complementary medicines are licensed and subject to TGA audit processes.

In light of the Pan crisis, it is appropriate for the TGA to review the nature and frequency of its audits.

Most countries have argued that low risk complementary medicines do not need full drug GMP standards of manufacture and that an ‘appropriate’ level of GMP standards should be developed in accordance with the ‘low risk’ nature of complementary medicines. Canada, the United States and New Zealand favour this approach.

(b) A National Register Underpins SAFETY

Unlike the US, NZ, UK, Canada etc, the Australian regulator requires all complementary medicines to be registered on the ARTG (Australian Register of Therapeutic Goods). By any measure, complementary medicines are intrinsically safer than pharmaceutical drugs, and as such they are generally placed on the ‘Listed’ category of the ARTG because they are considered “low risk” by the Government whereas pharmaceutical drugs are placed on the higher risk “Registered” category. ‘Listed’ products must have an “AUSTL No.” on the label and ‘Registered’ products must have an “AUSTR No.” on the label so that they can be clearly identified.

Because of the Government’s preoccupation with the notion that complementary medicines should be restricted to low level claims (i.e. low risk), this separation into listed and registered categories simply does not work. In 12 years since legislation was introduced, there is probably only one product (Glucosamine) that has got through the medical mindset that controls the Registered category.


(c) Evidence Based Claims Underpin EFFICACY

Claims for products are controlled by an evidence-based model whereby the owner of the registration is required to hold the appropriate evidence for the claims which must be included on the product register by law. Naturally these claims are subject to the ACCC’s Trade Practices Law as well as the Therapeutic Goods Law in relation to false and misleading statements. I contend that in this regard the law is more than adequate.

Naturally the regulator is reluctant to use Trade Practices Law for complementary medicines because, heaven forbid, the onus would then fall on the Government to prove the product claims are wrong. However, this is the model that now exists in the US, having been imposed on the regulator by elected Government when major consumer health issues were raised in the US in the early 90’s. This resulted in the DSHEA (Dietary Supplements Health Education Act) and the establishment of a National Centre for Complementary and Alternative Medicine (NCCAM) in the US.

The law is further underpinned by a co-regulatory approach that includes a Complaints Resolution system and an approval process that is mandatory for advertisements of all complementary medicines.

Many consumers and industry assert that the existing level of expertise and experience within the TGA is not adequate for the appropriate regulation of complementary medicines. This is not a reflection on Terry Slater as head of the TGA or indeed some of his senior staff, however, there are TGA staff considered by some as rather hostile to natural health products and may have exercised their authority in an overly partisan way. It appears that there is simply inadequate understanding of how complementary medicines work, or the philosophical background behind them. Policies and regulations continue to be developed by non-experts and industry invariably spends a large part of its time and resources in a confrontational role with the regulator, e.g., we understand that there may be only one employee within TGA who has formal training in herbal medicine. It has been suggested that the Complementary Medicines Evaluation Committee has lost relevant expertise in complementary medicines and appear to be moving to a more medico-orthodox mindset. The recent establishment of Trish Worth’s ‘expert’ committee is evidence of this
medico-orthodox mindset coming from the parliamentary office and from the regulator. The peak industry body was never consulted on the composition or terms of reference of this committee. To appoint our industry’s most vocal medico critic to that committee in the interests of ‘balance’ defies a fair and rational approach.

Just imagine the uproar in Canberra if there was a pharmaceutical ‘expert’ committee that had a bias towards complementary medicines. No wonder Trish Worth’s predecessor, Senator Grant Tambling, told me not to take on the pharmaceutical industry in Canberra, they are simply too powerful!

Should Complementary Medicines have the same scrutiny as drugs?

The claim that drugs and complementary medicines should be subjected to the same regulatory procedures is misguided, at best. Whilst both entities are regulated as drugs, it is entirely appropriate for the regulator to treat them differently even within the same Act and Regulations as is the case today. On the one hand, substances such as vitamins and herbs have been consumed for decades, if not hundreds of years, whereas most pharmaceutical drug products are produced from previously unknown chemical entities that have not existed on the planet before. The current system has classifications for ‘listed’ and ‘registered’ products that addresses these differences, based on an assessment of risk to public health. In general, Pharmaceutical drugs fall into the higher risk ‘registered’ category and Complementary Medicines fall in to the lower risk ‘listed’ category. This system generally works well for drugs but is not working adequately for complementary medicines.

Adverse Reactions

Despite there being widespread public use of complementary medicines, there is a very low level of adverse reactions reported. Of course, there will always be a few reported and invariably they will get wide media attention simply because they are so uncommon. On the other hand, our society accepts the much higher risks associated with pharmaceutical drugs. The Medications Safety Task Force in 2001 said that there are an estimated 80,000 hospital admissions each year as a result of adverse drug events, costing some $350 million to the health system.

Since the Pan crisis there has been a predictable increase in reporting of adverse reactions as consumers sought to blame Pan for their problems, however, in 2001 there were 23 adverse reactions to complementary medicines and some 80,000 to pharmaceutical drugs. No doubt there is room for some improvement in the present reporting system.

Medical Research and Complementary Medicine

The most significant review of medical research in Australia, the Wills Report 1999, reported that complementary medicines and indigenous health are in need of capacity building, and recommended training in research methods of complementary medicines and recognition by established researchers of health and medical research funding bodies. Yet in 2001 we spent a meagre $65,000 in research on complementary medicines versus $200 million in the pharmaceutical area. When 60% of Australian adults use complementary medicines regularly and some 80% of Australian GP’s refer patients for complementary treatments, it may be opportune, if not a responsibility, for Government to address this anomaly.


A designated proportion of say 10% - 20% of national health and medical research funding should be directed towards research projects into complementary medicines. Adequate research would dispel anxieties and mistaken beliefs about the efficacy of complementary medicines and would boost public confidence in a vital industry that receives virtually no Government support. The National Centre for Complementary & Alternate Medicine is funded
by the U.S. Government with a budget this year of approximately $A180 million.

Where Does Government Get Its Advice?

It is incredulous that what started as serious adverse reactions to an orthodox pharmaceutical drug (Travacalm HO) has turned into a tirade of condemnation of complementary and alternative medicine. Our detractors, both academic and political, had a media field day, which only serves to highlight the need for Government to have an accurate and reliable source of information totally independent from the regulator (TGA) with its inherent disposition to a pharma drug model of thinking.

In July 1999, Trish Worth’s predecessor, Senator Grant Tambling, said at the establishment of the Complementary Healthcare Consultative Forum that “the challenge for Governments and the healthcare industry is to find the balance between the need to improve market access for beneficial complementary healthcare products and the need to maintain consumer confidence through high regulatory standards based on ensuring safety”. At the time, Industry welcomed this initiative from government, however, Trish Worth has discontinued this forum.

The Complementary Medicines Evaluation Committee, (CMEC), was established at the time of the then Parliamentary Secretary, Senator Chris Ellison, to respond to industry concerns at the time about unfair pharma bias within the TGA. This Committee established a world best practice model for the evaluation of scientific and traditional claims for complementary medicines. Regretfully this Committee may be sanitised more towards the pharma model with government removing both the Executive Director of the Complementary Healthcare Council, Mrs Val Johanson, and Manly Medical doctor and Integrative Medicine Practitioner, Dr Joachim Fluhrer. It can be argued that they were due for replacement however their unique expertise has not been replaced.

A Complementary Medicines Advisory Committee should be established with expert knowledge in complementary medicines and alternate health practices. The CHC already has such an independent committee in place chaired by Professor Stephen Myers of Southern Cross University.


What Should Government Do?


Complementary medicines should be regulated as medicines. However, they require appropriate regulations administered by appropriately qualified regulators with experience in complementary medicine. The preferred option to best regulate natural health products seeks a greater level of separation from the existing TGA pharma model by establishing a Natural Health Products Authority.



Government should establish a National Centre for Complementary Medicines similar to the existing US counterpart organisation. This Centre could immediately explore the opportunity to reduce the costs of Government healthcare with the judicious use of complementary medicine.


Government (and Industry) should provide funding for more research into complementary medicines and alternative health practices.



Government should immediately remove GST on all complementary medicines listed on the ARTG.


Government should establish a Complementary Medicines Advisory Committee to independently advise the Minister on policy and regulatory issues.



Report of the Expert Committee on Complementary Medicines in the Health System

The Pan crisis of April 28, 2003 was a Class 1 or ‘life threatening’ recall of some 1600 low risk complementary medicines. These products were recalled because of the TGA’s genuine concerns about manufacturing practices contravening existing law, it was certainly not about questions of efficacy or any adverse reactions to Pan manufactured complementary medicines that may have been reported by the public. However, the medico-orthodox critics of complementary medicine came out of the woodwork to infer that complementary medicines are neither safe nor efficacious, this was really a gross and irresponsible distortion of the facts surrounding the Pan debacle.

The intense level of public and political debate that emerged needed to be addressed by government. Not surprisingly, what followed was the controversial appointment of an 18 member so-called ‘expert’ committee which despite intense lobbying from industry, had only one third of its membership with expertise and practical experience with complementary medicines. I find it difficult to consider someone as ‘expert’ when they are the most ardent critic of complementary medicines, no wonder the debate was ‘vigorous’ as reported by the Chairman. The inference from government at the time was that this committee would address the Pan/TGA issue, however this was largely avoided by the terms of reference which were a simple cut and paste from the National Medicines Policy (NMP) previously called National Drug Policy. The NMP is a framework created over a number of years by government for the quality use of drugs and or
pharmaceutical products but was conceived without input from the complementary medicines sector.

So an ‘expert’ committee that conceivably should have been reviewing issues associated with the TGA and Pan crisis and how to best avoid another crisis, became a committee “to examine complementary medicines and their role in the health system” as quoted by its Chairman. Naturally agendas for deliberation by the committee were provided by the TGA and conspicuously no submissions were accepted from outside the committee and, if received, were promptly returned. It is inconceivable that any review of the role of complementary medicines in the health system did not look at positive health outcomes from the use of complementary medicines or indeed the significant cost reduction to the national health bill by the judicious use of complementary medicines. In this respect the committee was a failure, notwithstanding that it did what its terms of reference dictated.

What this committee has effectively produced is several recommendations for more regulation, more penalties and more reviews that if unchallenged will simply shoehorn complementary medicines further down the path of the drug/pharma model certainly resulting in more cost and less access to consumers. On the other hand, there is potential here for the government to establish some incredibly worthwhile initiatives for our industry and for the Australian public.

In the debate that flows from this report, the industry and public who care about right of access and freedom of choice for complementary medicines must be vigilant and engaged. The orthodox medico pharma lobby will seek quite different outcomes to what we might believe to be fair and proper.

Having said that, it is important that we give deserved credit to a number of recommendations that emerged from this committee. In one part of the report there is acknowledgement that complementary medicines may provide lower risk and more cost effective options compared to other medicines (drugs). Whilst I would have thought that the COAG principles of government, including ‘minimum effective regulation’ could have led the committee to recommending a more appropriate regulatory environment for complementary medicines, it was pleasing to see the recommendations for future funding of complementary medicines research, even suggesting that there is a social responsibility for government to fund such research. The report highlights the funding disparity between complementary medicines and prescription drugs and OTC medicines and calls for this to be addressed.

Quality of ingredients, in particular herbal components has always been a difficult and concerning area and there needs to be industry acknowledgement that recommendations that will ensure improved quality standards of complementary medicines are deserving of our support and are in the best public interest. In fact the peak industry body, the CHC, recently released a Code of Practice for raw materials which is expected to be endorsed by the ACCC. It is important however, that there be wide industry consultation to ensure that any regulatory change is justified and in the consumer interest.

Government has always had a preoccupation with buttonholing complementary medicines into a category of only low level claims which flies in the face of much of the clinical research and established consumer usage of these products, so it was pleasing to see recommendations that a task group be convened to review the process of registration of complementary medicines. By any measure the current system of ‘registered’ as distinct from the ‘listed’ category of complementary medicines has failed miserably and is not in the consumer interest.

Industry has always believed that the law itself is generally adequate for consumer protection, but what is of concern is the application of law by those with a mindset that is rather hostile to complementary medicines. Inadequate understanding of how complementary medicines work or the philosophical differences to conventional drug medicines, has always meant that policies and
regulations are developed by non-experts and therefore industry spends a large part of its time and resources in what is clearly avoidable confrontation with the regulator. This stems from the fact that unlike most countries in the world, Australia chooses to regulate complementary medicines as drugs. A recent Canadian Government Review Committee properly constituted to look into natural health products, said that these products must not be treated strictly as either food or pharmaceutical products and has established a third category approach by establishing a Directorate of Natural Health Products headed up by an individual with naturopathic qualifications. It was therefore pleasing to note the Expert Committee’s recommendation that advisory bodies on the research and use of all medicines have representation from people with expertise and practical experience in the use of complementary medicine, even though consideration of a separate regulatory authority was not contemplated.

Industry and consumers would welcome the Committee’s recommendations to provide better access to reliable information about complementary medicines, our only reservation is that the information is not sanitised by dictates from a medico-orthodox mindset. The whole question of consumer access to responsible and accurate information in relation to complementary medicines
is an area of much debate with the regulator given the disparate views that exist. We would therefore welcome a hopefully independent study that determines the information and skill needs of healthcare professionals and of consumers in particular.

Although regulation of complementary healthcare practitioners is a State issue, it is understandable that a committee half comprised of western trained medicos would place considerable focus on these professions. Recommendations which include regulation and certification of practitioners, disciplinary systems and better standards of education and training are all laudable in concept but propose significant hurdles given the great variation in the way different modalities are practiced in the community. It is a major challenge for the professions. I just hope that in the process, we all get to understand why the majority of the Australian public, largely at their own expense, choose to patronise these practitioners when this report suggests how inadequate their practices and education may be.

In summary, the Expert Committee has produced a substantial document in a very short time frame and they are to be congratulated for that effort. The report contains both good and bad points, and we should be optimistically cautious about where government will lead us from here.




This document was written by:

Marcus C. Blackmore AM
Chairman
Blackmores Ltd
November 2003
Contact (02) 9951 0125
Fax (02) 9949 5270