E-DRUG: Consumers want pharmaceutical promotion law
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http://www.pharmainfocus.com.au/news.asp?newsid=3493
Posted 30 August 2010
As the Australian committee on promotion of therapeutic goods prepares to
meet for the second time this week, consumers are telling its inquiry that only legislation will ensure public health priorities are upheld.
In his July Position Paper on the Promotion of Therapeutic Goods,
Parliamentary Secretary for Health, Mark Butler asked that industry
strengthen and standardise self-regulation through developing an industry
framework for universal adherence to consistent industry-wide codes based on a common set of high level principles. In the paper Mr Butler warned that if consistent arrangements are not realised, legislative options option may be implemented.
The working group established to address issues raised in the paper is made
up of consumer and industry representatives and chaired by the CEO of the
Medical Technology Association of Australia, Anne Trimmer.
In a submission to the group, Health Action International (HAI), a global
network of consumers, public interest NGOs, health care providers,
academics, media and individuals, says there is a wide range of evidence to
show industry self-regulation is insufficient.
"For pharmaceutical promotion to be effective and enforceable there needs to be a legislative framework through which the government can lay out
principles and norms for compliance in respect of commitments to
transparency, independent monitoring., complaints procedures and any
subsequent sanctions," the HAI's submission said.
"Moreover," it said, "adherence to these principles and regulations should
be considered as a pre-requisite for any application for marketing
authorisation to the TGA."
It added that codes should be developed in partnership with all
stakeholders, however monitoring to the code, implementation and enforcement should be steered by one single independent body whose guiding principles are in line with the WHO Ethical Criteria for Medical Drug Promotion.
The Public Health Association of Australia Inc (PHAA) maintains that while
some self-regulation may be appropriate it must be overseen, monitored, and
checked. They raised concerns in their submission that under the current
rules, companies who are not members of a self-regulatory industry
association may be free from sanctions.
"The PHAA believes that independent monitoring; code revision and complaint
resolution would be more effectively and efficiently carried out under the
auspices of one self-regulatory Therapeutic Goods Promotional Authority
(TGPA) with representation from all stakeholders; rather than the current
plethora of industry sector code and complaint committees," they said.
They added that if industry wishes to contribute to funding the education of health professionals, the money should go to an independent central office to coordinate and oversee all requests for, or offers of, industry funding, and to receive and distribute these funds.
"This arms-length process should negate the possibility for companies to
badge their products as part of the process. All industry educational
scholarships and travel funding should also be coordinated through this
independent office, which would evaluate and choose recipients," they said.
In its submission, the Generic Medicines Industry Association welcomes the
position paper, and says it supports the establishment of high level
principles to achieve consistent standards across the different industry
sectors, and the working group.
A Department of Health spokesperson indicated that the submissions will not
be made public at this point. Those labelled confidential will not even be
viewed by the working group.
Simone du Toit [copied in the public interest]
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