Ken Harvey: The right touch

COMPLEMENTARY medicines are currently subject to an expert review of medicines and medical devices regulation, prompting a submission from Complementary Medicines Australia.

In its submission, made earlier this month, Complementary Medicines Australia (CMA) called for a “light touch — right-touch” approach to regulation, including the simplification of the existing regulatory framework, abolishing advertising pre-approvals for low-risk products, and disbanding of the Complaints Resolution Panel.
    
My submission agrees — in part.

I agree that the complementary medicine industry’s regulatory burden could be reduced by abolishing the current inconsistent and incomplete advertising pre-approval system, which is delegated to industry associations.

Under my proposal, the Therapeutic Goods Administration (TGA) advertising code would still apply, but all complaints would be sent to a strengthened TGA complementary medicines branch — eliminating the Complaints Resolution Panel — and the TGA would be given the power to apply timely and meaningful sanctions capable of deterring repeated regulatory violations.

A similar proposal was put forward in a 2013 TGA impact statement on regulating advertising to the public — recommendations to government that have been ignored for far too long.

In addition to these changes, post-marketing reviews by the TGA need to be at least doubled. The TGA’s information on 2014 complementary medicines compliance review outcomes showed 190 reviews were initiated in 2014, which represented 1.5% of all 12 300 listed medicines. This information also showed substantial levels of non-compliance continue to be detected (61% of the 181 targeted reviews; 27% of 41 the random reviews).

However, these figures do not include the many reviews that were aborted when sponsors delisted their products when notified of a TGA review — products that were often then relisted.

It’s doubtful that the current TGA post-marketing regime is achieving its aim of minimising consumers’ exposure to non-compliant complementary medicines. So, as well as more post-marketing reviews, the TGA needs to impose substantial penalties for non-compliance.

If increased fees paid by the complementary medicine industry are needed to achieve these aims, then so be it.

Complementary medicines are relatively low-risk products, but that does not mean they are without risk — particularly in relation to causing adverse effects from drug interactions.

Without independent assessment of the effectiveness of these products (and their side effects and interactions), how can consumers and health professionals make appropriate assessments of risk and benefit? Approved and consistent consumer medicine information (CMI) for complementary medicines is needed.

Complementary medicine sponsors should provide a summary of the evidence they use to self-certify the indications and claims for their product to the Australian Register of Therapeutic Goods. This public summary document should also be available on the sponsor’s website with the CMI for the product. This would help the TGA to conduct post-marketing reviews, allow third parties such as consumer organisations and health activists to more readily check the information provided, and educate consumers about the product’s risks and benefits.

Consumer organisations have suggested in many submissions that Australian product labels and promotions should be required to show a disclaimer similar to that used in the US. For example: “The claims made for this product have not been evaluated by Australian health authorities”.

A similar large sign should also be compulsory in pharmacies and health food shops selling these products.

The CMA has also proposed that regulatory duplication be cut through recognition of approvals by overseas regulators to provide faster access to new products. I do not agree. Why? One example is from Canada, where homeopathic vaccines purported to prevent polio, measles and pertussis are licenced.

Incentives are needed to stimulate more research on complementary medicines. Currently, sponsors get a much greater return on investing in hype and celebrity endorsement than on research.

Some research that has been conducted on complementary medicines and dietary supplements has mostly concluded there is inadequate evidence to support routine supplementation for primary prevention of chronic diseases. Variability in the composition of complementary medicines also makes extrapolating results from controlled clinical trials challenging.

For example, an Access Economics report on complementary medicine noted that it is unlikely that all St John’s wort products are equally effective. The report suggested that the standardisation of St John’s wort products would be required before these products could be recommended as an alternative to pharmaceutical antidepressants for mild to moderate depression.

Without appropriate regulation to ensure product quality, safety and effectiveness, these products lack validity, despite the substantial amount of money consumers spend on them.

In short, a touch more regulation is required so Australian consumers and health professionals can have confidence in complementary medicines.
 

Dr Ken Harvey is adjunct associate professor at the School of Public Health and Preventive Medicine, Monash University www.medreach.com.au