E-drug: Re: Estonian Violations of advertising regulations
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Dear Barbara + All,
Regarding pharmaceutical ad regulations in Sweden:
1. In your country, is enforcement of promotional regulations carried out
directly by the government, or delegated to the pharmaceutical industry?
The Swedish Medical Product Agency (MPA), a branch of the government,
surveys and regulates marketing of drugs. The legal base of this is a clause
in the Medical Product Law (L�kemedelslagen), that states that 'Marketing
information of medicines shall be up-to-date, factual and balanced. It shall
not be misleading.' A special board decides whether individual ads comply
with this legislation and the Pharma industry code of conduct (presumably
the IFPMA's code).
2. How much information is publicly available on advertisements and other
promotional activities that have been found to violate national
regulations?
Some information on advertisments that have been found to violate the rules,
is made public through the MPA newsletter. The motivations for the decisions
are summarized in 3 - 10 sentences. In the last issue, for example, the
following companies were fined (or rather, were asked to pay a 'board fee'
of) 50,000 SEK (5800 US$) each:
SmithKline Beecham (Panodil / paracetamol)
Eli Lilly (Evista / raloxifen)
UCB Pharma (Barcan / aceklofenac)
Pharmacia&Upjohn (Xalatan / latanoprost)
Pharmacia&Upjohn (Ido-E / vitamin E)
Pharmacia&Upjohn (Regaine / minoxidil)
Janssen-Cilag (Fungoral / ketoconazol)
MSD (Maxalt / rizatriptan).
A personal reflection: wouldn't it be interesting to have a central website
with information like this from a large number of countries? I am not sure
if MPA officials in different countries communicate on these issues, but I
suppose the EMEA has some kind of control of the situation in Europe, at least.
Best regards,
Staffan Svensson
Dept of Clinical Pharmacology, Gothenburg University
staffan.svensson@pharm.gu.se
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