E-drug: Re: Estonian Violations of advertising regulations
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Dear Barbara,
1. In your country, is enforcement of promotional regulations carried out
directly by the government, or delegated to the pharmaceutical industry?
In Australia, pharmaceutical promotion is regulated by the the Australian
Pharmaceutical Manufacturers Association (APMA) Code of Conduct for
prescription medicines and the Proprietary Medicines Association of Australia
(PMAA) Code of Practice for over-the-counter medicines. There is also the
Nutritional Foods Association of Australia Code which covers some of the
complementary medicines etc. These codes are underpinned by legislation
including the Therapeutic Goods Act and Trade Practices Act.
2. How much information is publicly available on advertisements and other
promotional activities that have been found to violate national
regulations?
The APMA and PMAA only publish details of code violations in their Annual
Reports which are mostly distributed to member companies, other individuals can
obtain copies upon request. Although the APMA Code of Conduct Annual Report
does state "this Annual Report be kept confidential within the health care
industry and not provided to any external audiences" The NFAA does not
publish code violations.
- Is enough detailed information on the ad, product, company, location of
activity made public so that health professionals or the public can know
when something they saw or participated in was found to violate
regulations?
The APMA Code of Conduct Annual Report for 1998 included details of the Company
and product, type of promotional material, complaint, company response, the
APMA Code of Conduct committee ruling, sanctions imposed, any appeals and the
results of the appeal. The PMAA Annual Report includes company, product, type
of promotional material, alleged breach and outcome. It is not always possible
to identify the exact promotional material in question from the reports.
- Is the reason behind the regulatory decision also made public? [for
example, promotion of unapproved indications, inadequate risk information
provided, incentives or bribes offered, etc]
Details of the APMA Code of Committee ruling include the section of the code
which was breached. eg misleading, disparaging comparison, unapproved
indication etc.
Over the last few years the APMA have substantially increased the information
published in the Annual report about code violations. However, one of the
national indicators for quality use of medicines in Australia is 'the number
of code breaches published in health professional journals". In the early
1990's in Australia, summary reports (which contained very little information)
were published in the Medical Journal of Australia, but this ceased in 1993 and
has not yet recommenced.
Best wishes
Libby Roughead
School of Pharmacy and Medical Sciences
University of South Australia
North Terrace
Adelaide 5000
South Australia
Australia
Ph: +61 8 8302 2179
Fax: +61 8 8302 2389
E-mail: libby.roughead@unisa.edu.au
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