Home' Australian Pharmacist : Australian Pharmacist November 2015 Contents Australian Pharmacist November 2015 I ©Pharmaceutical Society of Australia Ltd.
Report highlights regulatory
Regulation, compliance, and price pressure are slowing access to new
medicines, and undermining industry confidence in the current listing
process, according to the PwC report Challenges and Change -- a report on
the Australian pharmaceutical industry.
The report canvassed the views of
representatives from 23 organisations
including industry bodies and
pharmaceutical companies. More than
50% of companies surveyed had annual
turnovers in Australia of more than
Regulatory and market access
concerns dominated the responses,
with companies saying they were
experiencing an increased regulatory
burden across a range of areas.
The processes overseen by the
Therapeutic Goods Administration (TGA)
were cited as a key source of frustration.
65% of respondents believed the
processes around TGA registration had
not improved or worsened over the past
PwC Australia's health leader John
Cannings said there was universal
agreement in the industry on the
benefits of having an independent,
Australian regulatory agency for
approvals. However, an absence of
collaboration with overseas regulators
and scarcity of resources was slowing
approvals and preventing Australian
patients from accessing medicines
already available in other jurisdictions.
'What the industry is looking for is
more efficient processes and greater
collaboration with international
regulators,' he said.
'For example, the current process
includes a requirement for
Australian-specific clinical data, even in
instances where the drug has already
been sanctioned in the US and Europe.
'A "fast-track" approval mechanism
for drugs with high clinical need and
lifesaving therapies would be welcomed
by both the Australian industry
Another area of concern is the costs and
processes involved in getting medicines
recommended for subsidisation via the
Pharmaceutical Benefits Scheme (PBS).
The report found 72% of respondents
said the Pharmaceutical Benefits
Advisory Committee (PBAC) imposed a
significant regulatory burden in 2014.
This was up from 55% in 2012. As a
result, companies were becoming more
reluctant to present drugs for PBS listing.
A total of 87% of respondents
considered not applying to PBAC for
reimbursement in the past two years,
amid concerns that the resulting
PBS price would be uneconomic.
This compared with the reported 52% of
products being withdrawn or not
applied for in 2012.
However, according to Mr Cannings,
there are some benefits in having a
rigorous assessment before a product is
brought to market.
'Pharmaceutical companies should
understand that the Government
needs to balance the cost to taxpayers
against the clinical benefit of a new
drug,' he said. 'In that context, it makes
good business sense to only be applying
to register drugs that will deliver the
greatest benefit to patients, and the
greatest value to the taxpayer,' he said.
Medicines Australia CEO, Tim James,
said the PwC survey showed that MA's
member companies were facing an
increasingly difficult reimbursement
process, along with the Federal Budget
measures, leading to delayed access to
some new medicines.
NPS MedicineWise and Webstercare have
collaborated on the Medicinewise Report
to assist in reviewing antibiotics use for
urinary tract infections (UTIs) in residential
aged care facilities (RACFs).
The RACF Medicinewise Report enables
RACFs to identify patterns of medicine
use and reports are free to access via
pharmacies from the Webstercare
Medication Management Software.
The RACF Medicinewise Report, Antibiotics
for urinary tract infections, helps RACFs to:
• Regularly review antibiotic use for UTIs
• Understand and analyse antibiotic use
• Improve resident care in line with
• Identify what preventive treatments are
• Compare medicine use against
comparator data, and
• Identify residents who may benefit from
a review of their medicines.
NPS MedicineWise Chief Executive Officer
Dr Lynn Weekes said this collaboration
with Webstercare would support
improved care within RACFs.
'Reflecting on a facility's current practice
of prescribing of antibiotics for UTIs
is highly beneficial. For many people
treatment of asymptomatic bacteriuria is
usually not required.
Webstercare founder and Managing
Director Gerard Stevens, said NPS
MedicineWise and Webstercare were
committed to supporting the aged
'Webstercare shares NPS MedicineWise's
commitment to improving the quality
use of medicines for all Australians. This is
our second collaborative report and I am
very pleased it will help support that goal,
particularly with respect to the quality use
of antibiotics in the treatment of urinary
tract infections in residential aged care
Further information is available on the NPS
MedicineWise and Webstercare websites.
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