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At
that time most laboratories would provide guidance
to doctors defining the reference range of serum
(total) testosterone of 11 nmols —35 nmols
as being ‘within normal limits’ or ‘within
normal range’. So if a man was at the lower
end of the range and certainly if he was off the
bottom end of the scale, and he had a range
of characteristic symptoms, then doctors could
obtain an authority prescription for testosterone
replacement medication on subsidy under the PBS.
In
fact, because most GP’s have received little
or no formal training in the operation of hormones
in men, relatively few doctors were even considering
hormones as a possible cause factor, so few investigations
were taking place.
Amendments
brought in August 1999
These
amendments, which FOI documents reveal were intended
to increase restriction on access to hormone supplementation,
for men only, removed any role for the man’s
treating doctor in the diagnostic process of his
condition and eliminated consideration of a man’s
symptoms entirely.
Instead,
outside of a few defined exceptions, the government
introduced a rigid biochemical criteria whereby
two morning blood samples of serum testosterone,
taken on different mornings, must show results
of 8 nmols or less for a man to qualify for subsidy
on medication under the PBS.
Did
this break the law?
From
a legal standpoint we understand that both the
government and the consultative committee in relation
to the PBS — the Pharmaceutical Benefits
Advisory Committee (PBAC) — have the right
o be wrong medically.
The
pertinent question in relation to appeals to the
Federal Court is whether the law has been broken
by the introduction of these rules and their subsequent
implementation.
We
strongly believe that with proper legal representation,
there is evidence available to show that the law
has been broken on three counts le that the government
and PEAC have breached the following:
1.
The Sexual Discrimination Act
2.
The international Covenant on Civil and Political
Rights (ICCPR)
3.
The Administrative Decisions (Judicial Review
Act) 1977
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