In 2003, the Therapeutic Goods Administration
instituted a major recall of products made by Pan
Pharmaceuticals Limited. Later that year, an expert
committee produced 49 recommendations for complementary
medicines reform, many of which were
to be implemented by the proposed Australia New
Zealand Therapeutic Products Authority (ANZTPA).
In 2008, the Pan Pharmaceuticals affair reached
some conclusion in the courts, the ANZTPA had
been abandoned and the case for reform had
intensified. There was widespread and increasing
use of complementary medicines yet consumers
were often unaware that, unlike conventional medicines,
these medicines were not evaluated for
efficacy. The justification of this two-tiered regulatory
system was that complementary medicines
are relatively low-risk products. However low risk
does not mean no risk. A number of consumers
have been shown to use these products for conditions
where there is no evidence of effect, potentially
placing them at risk. In addition, promotion
often overstates their benefits while minimising and
sometimes denying known adverse effects and
drug interactions. Complaint procedures are overloaded
and the ?sanctions? available do not deter
repeat offenders. A number of regulatory reforms
have been suggested to overcome these problems;
they are reviewed in this paper.