Monday, August 25, 2014

Self Regulation

It's that time of year again where accountants across the country get very very busy.  It is a legal requirement in Australia for everyone to do a tax return at the end of the financial year which, as far as I can see, is because the Australian Tax Office (ATO) is completely incapable of doing its own job.  The ATO  is not the only big organisation in Australia which is set up to be a regulating body and yet delegates a lot of that responsibility to the very people it is meant to be regulating.

The Therapeutic Goods Administration (TGA) is the Australian equivalent to the MHRA or FDA and it is responsible for regulating all therapeutics available for use within Australia.  Well that's the theory, there is one big exception, natural, complementary and alternative medicines.

There is a common misconception that because something is "natural" it is safe, this is far from true a look at any number of poisonous plants and animals in the world makes this abundantly clear and yet this concept of natural equals safe is behind the TGA's decision to allow manufactures of these natural, complementary and alternative medicines to regulate their own products.

A recent audit of the TGA's self regulation policy showed that 90% of the listed products that went though this process were in violation of regulatory requirements.  These violations included mislabelled products, poor quality and misleading claims unsupported by any evidence.  These results are shocking but not to be unexpected when you consider that these products are made to make money, the manufacturers of these products only goal is financial gain.  Whether intentional or accidental, violations are inevitable when you allow the manufacturer of a product to then regulate it.

What I find most disturbing about this set up is these products are listed by the TGA as if they were properly regulated and this gives the general public the impression that these products may actually have been tested to ensure they are both safe and efficacious when the truth in the majority of cases is completely the contrary.

Australians are world famous for their laid back attitudes, but there has to be a limit.  When an organisation that is set up to be a regulating body, whether that's the tax office or the TGA, then it needs to do the job itself.  Self-regulation may save the organisations time and money, but it is open to abuse and in the case of the ATO it could cost the government millions in lost revenue and for the TGA it puts the general public at risk of serious harm.