ENLI makes several clarifications in the guidance to the Promotion Code
ENLI has made several changes and clarifications in its guidance to the Promotion Code. Plesner provides a brief overview of the changes here.
ENLI (Ethical Committee for the Pharmaceutical Industry) has recently published a revised guide to their Promotion Code. Below is a brief overview of the main changes:
Clarification of the scope of the Disease Awareness provisionIn the updated guidelines, the provision on exempting material on health and disease from the Promotion Code has been clarified, so that the focus area for such material must be information on health and diseases. On the other hand, the material may not mention disease treatment that is of a specific and indicative nature. If information on disease treatment is provided, such information must be limited, and the information may only be on a general level.
Clarification of requirements for compulsory information when supplementing information for SmPC
Compulsory information in connection with the marketing of medicinal products can be fulfilled by providing information on the summary of product characteristics (SmPC) supplemented with additional information, including:
- a reference to medicinpriser.dk, if it is an advertisement for a medicinal product that can only be purchased at the pharmacy,
- indication of the dispensing group (however, only for centrally authorised SmPCs, as this is already included for SmPCs authorised by the Danish Medicines Agency),
- information about reimbursement rules and
- the date of the last revision of the advertisement.
Clarification of requirements for mandatory information for dynamic banner adverts
In the case of dynamic banner advertisements, it must be considered whether it is perceived as a single advertisement when the advertisement consists of e.g., three banners running in a loop. This is a concrete assessment of whether the reader understands that the information in e.g., three banner adverts are related. ENLI recommends that it appears from the banner in question that this is part of a context, for example by indicating 1/3, 2/3, 3/3 on the individual banner. In addition, ENLI recommends that a temporal coherence between the banners is ensured.
Clarification regarding documentation of subject-specific expressions
ENLI specifies that it is necessary to document subject-specific expressions. In 2022, the Appeals Board made a decision in a case regarding pre-assessment of a newsletter for medical specialists, where a key technical term was used. The term "Highly effective treatment" is commonly used in the media and can also be found in research studies. However, the Appeals Board found that the use of the term did not meet the requirements for documentation, as it was an expression of a particular professional terminology in a specialised field, of which not every healthcare professional necessarily has knowledge.
New section on the use of environment/climate in comparative advertising
ENLI has added a separate section in the guidance on the use of environment/climate in comparative advertising. Here ENLI adds that in addition to using information on the efficacy and safety profile of the medicinal product, it is also possible to use information on the environment/climate in a comparative pharmaceutical advertisement. However, the use of this information is subject to the condition that the information on the environment/climate is only used as secondary and supplementary information to other professionally relevant information about the medicinal product, and that it is thus not the primary differentiating element in the advertisement.
Expansion of the requirement for professionalism under special conditions regarding continuing educational meeting presentations on the environment/climate (Sec. 13(1))
The interpretation of the requirement for professionalism has been expanded by the Appeals Board, which is now reflected in the guidelines.
The requirement for professionalism has thus been extended to also cover environmental consequences of the use of medicinal products.
ENLI puts forward a number of criteria for submissions on climate/environment and sustainability:
- Such submissions must primarily aim to provide healthcare professionals with relevant facts for a better understanding of the significance of climate effects for the work of healthcare professionals,
- No mention of specific medicinal products shall be made in the context of such submissions; and
- The review of environmental issues in general must not directly or indirectly be characterised as, or be perceived as, advertising for medicinal products
Clarification that an exhibition stand is a commercial area and not an integral part of a continuing educational meeting (Art. 18(1))
ENLI clarifies that an exhibition stand constitutes a commercial area, and thus not an integral part of a scientific congress. Therefore, the advertising rules apply to exhibition stands, and these cannot be juxtaposed with a continuing educational meeting. Therefore, the exhibition stand does not fulfil the conditions for distributing practical meeting equipment such as bags /pouches for use with the material distributed on the stand.
The full guidance can be found at www.enli.dk. The specific changes to the guidance can be found in the change log at the end of the document.