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 as consultants.

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 Code.

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 43, respectively.

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