Stronger self-regulation?
July 1, 2010
THE Federal Government has
today released a proposal paper
calling for stronger self-regulation
by the pharmaceutical and
therapeutic industries in relation to
their promotional activities directed
at healthcare professionals.
“Doctors and other health
professionals should prescribe
drugs or medical devices because
of the benefit to their patients, not
because they could receive an
incentive or a gift,” said Parliamentary
Secretary for Health, Mark Butler.
As part of its position, the
Government is calling on all
members of the therapeutic goods
industry to band together to
develop stronger standards and
enforcement for the promotion of
medicines and devices to
healthcare professionals.
“If the industry cannot provide
the tough self-regulation that
consumers deserve, the
Government will have to bring in
legislation,” Butler said.
Butler also hinted that if
“consistent arrangements” were
not realised in the near future,
then legislative options could be
put in place as early as 2012.
The paper itself, stipulates that
the current range of promotional
codes, existent across a number of
the therapeutic goods industry
associations are “inconsistent in
terms of their requirements,
application, enforcement and
penalties” and have the potential
to undermine public confidence in
the public sector.
The paper also argues that
current self-regulation codes have
“created an uneven playing field”
within the therapeutic goods
industry.
As such, it is argued that the
industry needs to strengthen and
standardise self-regulation through
the development of an industrywide
framework based on a
“common set of high principals”.
Suggested principals include:
common core standards; principles
of conduct including specific
elements required for each code;
and governance arrangements
such as compliance training,
reporting and independent
complaint mechanisms.
“The application process for the
registration of these products on
the Australian Register of Therapeutic
Goods would provide an opportunity
for sponsors to nominate the code
with which they intended to
comply,” the paper said.
The Government has also said
that in order for the proposed code
to be effective, “there is a need to
ensure the standards for conduct
of healthcare professionals align
with the standards expected of the
therapeutic goods industry”.
The consultation paper on
advertising is now open for
comment until 27 Aug - for info
see www.tga.gov.au.
The above article was sent to subscribers in Pharmacy Daily's issue from 01 Jul 10To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 01 Jul 10
