The industry body, Complementary Medicines Australia has responded to the Government’s call for Submissions on the Regulation of Complementary Medicines by arguing for appropriate regulation commensurate with the low risk profile of these products.
My own submission agrees with some but not all of CM Australia’s suggestions.
I agree that industry’s regulatory burden could be reduced by abolishing the current inconsistent and incomplete advertising pre-approval system delegated to industry associations. The Therapeutic Goods Advertising Code would still need to apply; all complaints would be sent to a strengthened TGA Complementary Medicines Branch (thereby eliminating the Complaints Resolution Panel) and the TGA needs the power to apply timely and meaningful sanctions capable of deterring repeated regulatory violations. In short, option 2 of proposal 3 and 4 in the 2013 “TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public” needs to be implemented. Recommendations from the TGA to government based on this consultation have remained unactioned for far too long!
In addition, post-marketing reviews by the TGA needs to be at least doubled. The TGA Complementary Medicine Compliance Review for January to December 2014 showed 190 reviews initiated (9.5% of around 2000 new listed medicines or 1.5% of all 12300 listed medicines). Substantial levels of non-compliance continue to be detected (61% of 181 target reviews; 27% of 41 random reviews). In addition, these figures do not include many reviews aborted by sponsors de-listing the products upon notification of a review (and then often re-listing the same product).
It’s doubtful that the current TGA post-marketing regime is achieving its aim of minimising exposure of consumers to non-compliant complementary medicines. I have suggested that the number of post-marketing reviews conducted by the TGA needs to be at least doubled with (as said before) substantial penalties for regulatory non-compliance. If the fees paid by the complementary medicine industry need to be increased to make this happen, so be it.
It is accepted that complementary medicines are relatively low-risk products, but that does not mean that they are without risk including the production of adverse effects and drug interactions. In addition, without independent assessment of the effectiveness of these products (and their side-effects and interactions) how can consumers and health professionals make an appropriate assessment between risk and benefit? There is a need for approved and consistent consumer medicine information (CMI) for complementary medicines that provides this important information.
I have suggested a small addition to the current regulatory system: make the sponsor add a summary of the evidence they use to self-certify the indications and claims for their product to the ARTG Public Summary document (and the sponsor’s web site) together with appropriate Consumer Medicines Information (CMI). This would assist the TGA in conducting post-marketing reviews; allow 3rd parties such as consumer organisations and health activists to more readily check the information provided, and educate consumers about product risks and benefits.
In addition, as consumers organisations have suggested in many submission, all AUST L product labels and promotion should be required to show a disclaimer similar to that used by the U.S. FDA, for example, “The claims made for this product have not been evaluated by Australian health authorities”. A similar large sign should also be placed above the shelves of pharmacy and health food shops containing these products.
I do not agree with the proposal for mutual recognition of overseas regulators to facilitate the entry of new Listable substances. Both Canada and the USA have been suggested. The former licences homeopathic vaccines purported to prevent polio, measles, and pertussis while the latter’s regulation of dietary supplements also has numerous flaws.
Finally, I agree that there is a need to incentivise innovation in complementary medicines. Currently, sponsors get a much greater return on investing in hype and celebrity endorsement rather than research.
Public health research on complementary medicines / dietary supplements has largely concluded that the evidence to support routine supplementation for primary and secondary prevention of chronic diseases is inadequate. However, the variability in the composition of complementary medicines makes extrapolating results obtained from controlled clinical trials challenging. For example, an Access Economic report noted that it is unlikely that all St John’s wort products marketed are equally effective. They suggested that standardisation of St John’s wort products would be required before these products could be recommended as an alternative to pharmaceutical anti‐depressants for mild to moderated depression.
Without appropriate regulation to ensure product quality, safety and effectiveness, the preponderance of evidence collected on complementary medicines / dietary supplements may be confounded by unmeasured variability in the products used and therefore lack validity. In addition, the value of the substantial expenditure on these products remains unsubstantiated.
In conclusion, a touch more regulation is required before Australian consumers and health professionals can have confidence in complementary medicines.