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Compliance with the SmPC and the Presentation of Non-Registration Studies in Advertising
Overview
Informing healthcare professionals about the latest findings from studies related to medicinal products is crucial for ensuring effective and safe patient care. Access to the most recent scientific knowledge allows physicians to better understand the effects and potential side effects of medications, leading to more informed prescribing decisions.
For such reasons, pharmaceutical companies often use data and claims substantiated by studies that are not included in the SmPC. However, the use of such non-registration studies in advertising is viewed differently across various EU jurisdictions. In some countries, these newer findings are considered problematic if not included in the SmPC, while other countries allow their use under certain (and typically strict) conditions.
According to Article 87(2) of Directive 2001/83/EC on the Community code relating to medicinal products for human use (Directive 2001/83), all medicinal product advertising must comply with the particulars listed in the summary of product characteristics (SmPC).
In its well-known Novo Nordisk judgment from 2011, the Court of Justice of the European Union (CJEU) has clarified, however, that the Directive does not mandate all claims in advertising to be contained in, or be deducible from, the SmPC. Moreover, all the elements of the advertising must not be identical to those contained in the SmPC. The advertising may contain additional claims to the mandatory SmPC, provided that these claims:
i) confirm or refine, are compatible with and do not misrepresent the SmPC; and
ii) they represent the medicinal product objectively, without exaggerating its characteristics, are not misleading, are accurate, up-to-date and sufficiently complete and, in the case of citations from scientific papers, are faithfully reproduced with an accurate indication of their source.[1]
Despite these harmonizing rules and CJEU guidelines, nowadays practical application still varies across Member States, particularly regarding the use of non-registration studies and their outcomes in advertising. This article explores selected national approaches to this issue.
National Approaches
Belgium: Defined conditions for studies not included in the SmPC
Belgium’s regulatory framework permits the use of studies not included in the registration file, provided certain conditions are met:
- The study must be published in a peer-reviewed journal.
- The original publication must be available upon request.
- Advertising must not reference studies reporting data on off-label use or outcomes unapproved during registration, i.e. the study must confirm the already approved data.[2]
Czech Republic: Strict Interpretation of SmPC Compliance and Limited Practical Application of Novo Nordisk Principles
While Czech authorities formally refer to the CJEU’s Novo Nordisk judgment, their approach to SmPC compliance in pharmaceutical advertising remains highly restrictive. In practice, only minor refinements or clarifications of the SmPC are permitted, and any claims perceived as expanding upon the SmPC are likely to be challenged.
- Limited acceptance of new studies not included in SmPC: Although studies outside of those included in the registration dossier are not outright prohibited from being referenced in advertising, authorities impose strict conditions on their use. Claims derived from such studies – especially those presenting long-term efficacy and safety data – are regarded as introducing substantive new information and cannot be included in advertising unless explicitly reflected in the SmPC.
- Restrictions on comparative claims: Claims based on comparative studies are prohibited if the comparison of active ingredients is not explicitly addressed in SmPC.
Germany: Accurate interpretation of study results
It is a well-established practice in Germany that studies outside the SmPC may be used. The legal disputes about pharmaceutical advertising are therefore rather whether the claims in the advertising are covered by the study cited from a scientific point of view. Germany emphasizes the so-called “gold standard studies” and accurate interpretation of their results in advertising. Key requirements include:
- Claims must be backed by scientifically reliable studies, typically randomized, placebo-controlled, double-blind trials published in peer-reviewed journals.
- Retrospective analyses (e.g. subgroup analyses or meta-analyses) require clear disclosure of their design, methodology, and limitations.
- Even SmPC-compliant claims can be deemed misleading if newer evidence undermines their validity.
Sweden: Strict adherence to SmPC
In Sweden, the authorities usually take a strict approach when interpreting compliance with the SmPC and possibilities to present new information in the advertising material are limited. It is permissible to complement information in the SmPC with claims that follow from studies and medical journals according to a judgment from the Court of Justice of the European Union (Case no C-249/09) as well as the Swedish self-regulatory body NBL’s (Sw. Nämnden för Bedömning av Läkemedelsinformation) case law. However, the Swedish Medical Products Agency has taken a very strict stance on accuracy and substantiation when it comes to referring to studies, especially if there are also other studies on the medicinal product that have a different or less positive outcome.
It is furthermore common for Swedish pharmaceutical companies to report competitors if they suspect that claims are e.g., inconsistent with the SmPC, or misleading.
Conclusion
The interpretation and application of Directive 2001/83 regarding the use of non-registration studies in advertising differ significantly among Member States. While some jurisdictions adopt a flexible approach, prioritizing the dissemination of robust and up-to-date scientific information, others maintain stricter requirements to ensure alignment with approved SmPC content, and practically require that all parameters are incorporated in the registration documentation (that, however, does not happen in real-time).
Such differences highlight the need for companies operating in multiple jurisdictions to carefully navigate national regulations to ensure compliance while effectively communicating scientific advancements.
Authors: Kateřina Slavíková, Denisa Fuchsová
[1] Case C-249/09 Novo Nordisk AS v Ravimiamet, Judgment of the Court (Third Chamber) of 5 May 2011, ECLI:EU:C:2011:272.
[2] Federal Agency for Medicines and Health Products (FAMHP) – Advertising intended for healthcare professionals, available at: https://www.famhp.be/sites/default/files/downloads/Advertising%20for%20HP%20EN.pdf.