E-drug: Re: Advertising regulations (cont'd)
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Dear Barbara, Staffan and the rest of you,
I�ve some additional comments to Staffans description of the Swedish system
for enforcement of promotional regulations concerning pharmaceuticals.
It is true that according to the current law the responsibility for
surveillance of adherence to regulations is the Medical Products Agency who
is supposed to take legal actions when necessary. However, the
responsibility has in fact been delegated to the pharmaceutical industry who
has started two "independent" bodies - IGM=Informationsgranskningsmannen (an
ombudsman) and NBL=N�mnden f�r bed�mning av l�kemedelsinformation (The
Council for Assessment of Pharmaceutical Information) which supervises the
activities of the ombudsman. The ombudsman himself is a physician chosen and
paid by the L�kemedelsindustrif�reningen (the association of pharmaceutical
companies in Sweden), the council consists of representatives from the
pharmaceutical companies, the Swedish Medical Association and laypersons.
The Medical Products Agency reports suspected violations to NBL for
evaluation and action (most often a fine of 50 000 SEK, approx 5 500 ECU)
The system is considered to function quite well, but the result is of course
more of a kind of accreditation of established rules of conduct between the
companies. This is also obvious in the fact that the majority of cases is a
case of one company versus another. The result is not always in line with
the the best interest of the society.
I do however think that the systems works as good as anyone can expect and
there is probably very little that can be improved in its current form. The
question is of course whether it is the best form. And I'm still very
disappointed that the official journal of the Swedish Medical Association -
L�kartidningen - does not automatically report all the decisions made by IGM
and NBL.
Mikael Hoffmann
Senior consultant
Dpt of Clinical Pharmacology
University Hospital of Link�ping, Sweden
Mikael.Hoffmann@lio.se
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