ENLI clarifies the rules on the use of HCPs as consultants
Just before Christmas, following debate in the Danish media on
the Industry's use of HCPs as consultants, the Danish Industry
Board, ENLI, clarified the rules on the Industry's use of HCPs
ENLI underlined that compliance with the Code will always be the
pharmaceutical company's responsibility, regardless of whether
the activity has been handled by a consultant.
Further, ENLI emphasized that payment for the HCP's services
only can be paid in cash, which means that gift cards or the like
are not considered compliant modes of payment, and that cooperation
with HCPs requires prior permission from the Danish Medicinal
Agency. It was also noted that if the activity is considered
advertising, notification should be given to ENLI in accordance
with the rules in the Code.
Update of the Advertising Code and the Guidelines
1 January 2012 ENLI launched a modified and updated version of
the Industry Code of advertising practice and the Guideline on the
Overview of changes in the Code:
Samples of medicinal products can only be distributed within
the first two years of launch
Medical devices defined as medicine under the law are now also
included in the definition of medicine in terms of the Code.
Overview of most important changes in the Guideline:
Special words: The appeal board has now confirmed that the word
"effective" is to be used only if 100% cure can be
documented. The word "safety" should never be used.
Sponsorship of participation in conferences etc.: Until a final
programme is set only non-binding invitations can be sent out.
Notification: of sponsorships of conferences etc. are to be
given 10 working days ahead of the departure date.
The Code and the Guideline can be found in Danish at ENLI's homepage, unfortunately no English
version is available. There is a modification log at pages 21 and
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guide to the subject matter. Specialist advice should be sought
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There have been specific rules governing the promotion of medicinal products in Turkey since the beginning of the 90’s.
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