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12 November 2009
MEDIA RELEASE
Red tape burden on over-the-counter medicines inhibiting the take-up
of patient self care
Australia’s system of regulating non-prescription medicines could benefit from the
experience of the UK health system, which has seen a cut in red tape, more streamlined
processes for industry and more timely access to medicines for the public following a
shift to a more risk-based approach, the Australian Self-Medication Industry (ASMI)
Conference in Sydney heard today.
Keynote international speaker,
Chris Horsey, is Head of Better Regulation in the
Department of Health
in England, which,
working with the UK medicines regulator and
the pharmaceutical industry (PAGB),
has implemented
an internationally acclaimed
program
to better regulate medicines, known as the Better Regulation of Medicines
Initiative (BROMI).
Working in partnership with the industry, the regulator, the Medicines & Healthcare
products Regulatory Agency (MHRA), has taken a leading role in a risk-based approach
to over-the-counter (OTC) medicines regulation.
“The outcome has been to deliver new and updated medicines to patients faster,
minimise the burden on industry and free-up industry and the regulator to focus on
innovation and safety,” Mr Horsey said.
“The perception of risk moves over time and as medicines move through the cycle and
become OTC, the risk significantly diminishes. The level of regulatory oversight should
match the level of risk as far as possible, ensuring the public are protected, at all times,”
he said.
The Executive Director of the Australian Self-Medication, Juliet Seifert, said some of the
initiatives implemented in the UK system should be examined in Australia, where light
touch regulation is the exception rather than the rule.
“Regulatory
compliance imposes a heavy cost on industry and is increasingly out of
step with the direction of health policy with its focus on promoting
self care and
improved preventative health.
“Increasing access to proven and safe non-prescription medicines also has the capacity
to reduce the burden on doctors who face backlogs
from the treatment of patients who
present with easily treatable minor ailments,” Ms Seifert said.
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The ASMI conference, titled: Self Care: How much is you responsibility?’ heard from
other
speakers including the Federal Minister
for Health & Ageing, Nicola Roxon, the
Minister for Small Business, Independent Contractors and the Service Economy, and
Minister Assisting the Finance Minister on Deregulation, Dr Craig Emerson, and the
Parliamentary Secretary for Health, Mark Butler.
Cavan Redmond, Group President, Pfizer Diversified Businesses, said it was time for a
fundamental re-think of the regulation of over-the-counter medicines, so that products
with lower risk and extended use were not subject to the same rigorous and costly
assessment as higher risk medicines.
“In order to protect patient choice and avoid crippling an already overburdened
healthcare system, we must refrain from viewing non-prescription medicines as
prescription medicines and
we must
instigate a new system whereby products are
evaluated according to the ‘sliding scale of risk and benefit’,” Mr Redmond said.
The US-based industry body representing the OTC sector, the Consumer Healthcare
Products Association (CHPA) noted a
change in risk and perception that was
characterised by recent tougher controls surrounding children’s cough and cold
medicines which has recently been foreshadowed in Australia.
The President of CHPA, Dr Linda Suydam said that industry and regulators were under
greater scrutiny which contributed to calls for enhanced
safety in some categories of
medicines, and which saw the crackdown on paediatric cough and cold products spread
from the US to the UK, Canada and Australia.
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About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care
industry representing consumer healthcare products including over-the-counter medicines and complementary
medicines. ASMI’s mission is to promote better health through responsible self-care. This means ensuring that safe
and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage
responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad
Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298
bbowden@bowmac.com.au
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