Home' Australian Pharmacist : Australian Pharmacist October 2014 Contents Australian Pharmacist October 2014 I ©Pharmaceutical Society of Australia Ltd.
Requirement of quality
In the past, prospective pharmacists
were not overly concerned if their
application was not complete or
evidence was missing. That was for two
reasons: First, the name of the game was
to get the application lodged before
any competing application was lodged
and secondly, if the ACPA recommended
against approval because it wasn't
satisfied with respect to some of the
evidence, then the gaps in the evidence
could be filled later when the decision
was appealed. But as discussed above,
being first in line does not come with
the security that it once did. Also, the
introduction of the current Pharmacy
Rules brought in a new provision
(section 9) which prevents applicants
from substituting their applications with
further material (even on appeal) unless
the ACPA requests for such material to
be provided. That means that the initial
application may well be the only chance
the applicant has to provide material to
obtain the approval.
The current regime aims to have
pharmacists, from the outset,
gather and obtain strong evidence
and documentation in support of
any application. More than ever,
an application should be carefully
considered and properly compiled.
Even then a favourable recommendation
will not be guaranteed, but a hurried or
incomplete application will significantly
increase the risk that an application
will be unsuccessful. If that happens,
the door for a competitor will be left ajar
and even if the gaps in the application
can be filled or it can be shown that
the ACPA decided the application
incorrectly, the chance to obtain the
approval may already be lost by the time
an appeal is heard.
PBS Approvals are valuable, not only
because they are not easily obtained,
but because they are a prerequisite
for operating a pharmacy business.
The accepted view is that the legislative
regime is concerned with members
of the public having proper access to
pharmaceutical benefits. However,
another aspect of the system is that
those pharmacists who hold approvals
(in some cases the only approval in
the town or specific area), will seek
to maintain their market share by
restricting the opportunity for other
pharmacists to obtain an approval and
ultimately compete for their market
share in the pharmacy business.
That makes it even more important for
applicants to put their best foot forward
when making an application. Not only
will they be competing with other
pharmacists for that particular approval,
but the incumbent pharmacists may
also be attempting to thwart the
application process, by either attacking
the merits of the application made by
the potential competitor or by lodging
their own application. If nothing else,
the incumbent will often (and from
a commercial perspective probably
should) attempt to prevent a competing
"THE CURRENT REGIME AIMS TO HAVE PHARMACISTS, FROM
THE OUTSET, GATHER AND OBTAIN STRONG EVIDENCE AND
DOCUMENTATION IN SUPPORT OF ANY APPLICATION. "
application from being approved. If that
cannot be achieved, he or she might just
try to delay the process.
The days of rushing to the front of the
queue are not entirely over. The ACPA's
policy is to still assess applications in
the order in which they are received.
But the Yu decision, coupled with the
restriction that section 9 poses, means
that being first is no longer the only
consideration. Under the current regime,
it is clear that prospective pharmacists
who choose not to put together
comprehensive applications will now do
so at considerable risk.
1. National Health Act s 89(a).
2. National Health Act s 90.
3. s 90A of the National Health Act allows the Minister
to approve unsuccessful applications if satisfied that
without an approval the community will be left without
'reasonable access' to pharmaceutical benefits, but that is
at a purely discretionary power. Most requests are refused
by the Minister.
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