Regulation not always in public’s interest
PREVENTIVE healthcare strategies are described by the federal Government ‘‘ as a first-order economic challenge’’ because they hold the key to increasing work attendance rates and productivity, as well as easing pressure on the overall health budget.
The Complementary Healthcare Council (CHC) endorses this view and has long argued that complementary healthcare products have an integral role to play in assisting the public with preventive healthcare. Consumers themselves recognise this, which is why demand for quality products continues to grow.
For this reason, arguments calling for major changes to the regulatory system which govern complementary medicines are not in the public interest. What needs to be injected into the debate is some realism regarding the very tangible benefits offered by a diverse range of complementary medicines relative to the exceptionally low risk they pose for the consumer.
The CHC considers consumer interests to be primary in all that we do. For this reason, ensuring consumers have access to safe, affordable and efficacious products to assist them maintain optimum health is something we take very seriously. We engage readily with all those who are genuinely interested in proposing changes which will benefit the public. However, arguments proposed in the Medical Journal of Australia in January (2008;188:21-25, reported in WeekendHealth on January 12-13), suggesting complementary and alternative medicines should undergo the same degree of evaluation as pharmaceutical drugs, are misleading and run counter to consumer interests.
We need to remind ourselves of critical facts when we contemplate substantive revision to the regulation of complementary medicines. In 2003, the previous Government commissioned an expert committee on complementary medicines in the health system. Its terms of reference specifically included consideration of whether the existing national system of regulatory controls regarding complementary medicines met appropriate standards of quality, safety and efficacy.
The expert committee, comprised largely of medical and pharmaceutical professionals, concluded that the current regulatory system provided the level of scrutiny and evaluation consistent with the level of risk, and was therefore appropriate.
Later there was a further detailed review of the system in the lead-up to the implementa- tion of a joint regulatory scheme (since abandoned) with New Zealand. Once again the structure of the current system was endorsed. Why then, should we seek to revisit the issue, given these recently comprehensive reviews?
It is important to note that all ingredients used in listed complementary medicines have been reviewed and deemed safe by the Complementary Medicines Evaluation Committee (CMEC).
When considering whether complementary medicines were effective, the expert commit- tee considered that the existing guidelines for levels of evidence provided sufficient framework to assess efficacy. Sponsors of complementary medicines are required to hold evidence of their products’ stability and efficacy, and certify so at the time of listing. This data can be requested and reviewed at any time by the TGA. Concerns regarding to what extent the TGA adequately audits products potentially points to a resource issue — not a failing of the listing process itself.
However, regarding efficacy, no medicine whether registered or not, works for everyone who uses it every time they use it. Further, as with listed medicines, many registered medicines such as common analgesics, antifungals and cough remedies are based on well-known ingredients that are not submitted to a full safety and efficacy evaluation each time a sponsor wishes to launch a new brand.
Interestingly, the expert committee noted that that this framework may not be well understood by either practitioners or consumers and recommended that educational information be disseminated. The CHC strongly supports addressing this weakness.
For the detractors of complementary medicines, a vexed issue relates to consumers being duped by false or misleading advertising on some complementary healthcare products. The Complementary Healthcare Council reiterates that advertising of all non-prescription medicines must conform to the strict requirements of the Therapeutic Goods Advertising Code. Sanctions apply for breaches of those requirements.
We believe that enforcement of such sanctions is a necessary and fitting response to those who fail to comply with existing requirements, and argue additional resources should be made available to the TGA to ensure this happens. Quite simply, let’s implement the system we currently have in its entirety before determining that any changes are necessary.
As with all regulatory systems, the Comple- mentary Healthcare Council acknowledges there is always room for improvement and we support informed measures that do so. But we also believe that in the light of increased consumer demand, government policy should better acknowledge the vital contribution complementary medicines play in Australia’s healthcare system. Specifically, we propose the following: Education of medical/healthcare practitioners of the low-risk complementary medicine/healthcare options available for patients where relevant,
Education and raising the awareness of the community about complementary healthcare options to enable them to make informed decisions in relation to their healthcare and health maintenance,
Generation of data/information on complementary medicines in relation to clinical effectiveness and economic contribution to the healthcare budget in order to underpin balanced policy and clinical decision making.
Australia currently has one of the most highly regulated systems in the world. The risk posed by the products, relative to their benefit is justly reflected in our existing legislative provisions. Increased regulation will result in low-risk, efficacious products becoming less accessible and affordable to the public. Tony Lewis is executive director of the Complementary Healthcare Council
Complementary medicines: It’s important that they are affordable and efficacious