Strict rules and hidden pitfalls: the challenges of marketing medicinal products in Sweden and the Nordics
Av Leif Lindau
on 24 March, 2025
The marketing and communication of medicinal products in Sweden and the Nordic countries is strictly regulated to ensure that the information is factual, balanced and not misleading. This regulatory framework aims to protect both healthcare professionals and the general public from potentially harmful or misleading information. In Sweden, the Swedish Association of the Pharmaceutical Industry (Lif) plays a central role in providing and monitoring compliance with the Ethical rules for the pharmaceutical industry in Sweden (LER). Here we have summarized some of the most important guidelines.
Basic principles of the LER
The LER complements existing legislation and regulations and covers several key areas:
- Information on medicinal products: Information on medicinal products shall contain accurate, objective, meaningful and balanced factual information relating, to the extent necessary, to both the positive and negative properties of the medicinal products. The information may only relate to medicinal products that have been granted marketing authorization in Sweden.
- Comply with the Summary of Product Characteristics (SPC): All marketing must comply with the medicine's Summary of Product Characteristics (SPC), which is the document established at the time of the authorization of the medicine. This ensures that only verified and approved information is communicated.
- Interactions with healthcare professionals: The regulations specify how pharmaceutical companies may interact with healthcare professionals to avoid conflicts of interest and ensure that collaborations are conducted in an ethical manner.
- Relationships with advocacy organizations: There are clear guidelines on how companies can engage with patient associations and other organizations to ensure transparency and integrity in these relationships.
Based on international guidelines
The information rules are based on the existing legal framework - the Marketing Practices Act and case law, as well as the provisions on information on and advertising of medicines set out in national and EU pharmaceutical legislation and other regulations, or contained in government regulations.
The information rules are also based on extra-legal standards such as the ICC Code of Advertising and Marketing Communication and the EFPIA Code of Practice, adopted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The rules are in line with the WHO Code of Ethics for the Promotion of Medicines and the IFPMA Code of Practice.
An important part of the international regulations is that each national industry organization must have a Compliance Officer, who is responsible for preventive work, such as advice and training. The Compliance Officer is also the contact person for IFPMA's Code Compliance Network.
What constitutes good practice in the field of pharmaceutical information is also highlighted by other extra-legal standards, such as the ICC/ESOMAR International Rules for Market Research.
Self-action systems and monitoring
To maintain high ethical standards in the industry, Lif has established a comprehensive self-regulation system:
- Industry's Information Examiner Committee (IGN): The IGN reviews pharmaceutical information and marketing on an ongoing basis to ensure that they comply with good industry practice and LER. Penalties can be imposed on companies for non-compliance.
- Information Practices Committee (NBL): the NBL is made up of representatives from different sectors and deals with cases related to the compliance of medicinal product information with ethical guidelines.
Executive summary
Navigating the regulatory framework surrounding the communication and promotion of medicines in Sweden and the Nordic countries requires diligence and a deep understanding of both legal and ethical guidelines. By following the LER and adapting marketing strategies to the specific requirements of different channels, pharmaceutical companies can ensure that their communications are both effective and responsible. This not only protects consumers but also strengthens trust in the industry as a whole.
For more information please visit Lif.
In-depth knowledge of the regulatory framework
Navigator has been helping life sciences companies navigate complex regulations, strengthen their brands and communicate effectively for more than 40 years. With an in-depth understanding of the healthcare sector, communications and marketing regulations, we develop tailored strategies that drive business growth and create long-term value.
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