Updates to the Ethical Rules of the Pharmaceutical Industry
On 29 September 2025, amendments to the Ethical Rules for the Pharmaceutical Industry (LER) entered into force. These rules form a key framework governing how pharmaceutical companies communicate and collaborate with healthcare professionals. Managed by the Swedish Association of the Pharmaceutical Industry (Lif), LER complements existing legislation, regulatory provisions, and directives issued by relevant authorities.
Below is a summary of the most significant changes to LER, particularly relevant for stakeholders across the industry.
Minimum Information in Patient Materials
The requirement to include certain minimum information in patient brochures and other support materials distributed by healthcare professionals to patients prescribed a medicine has been removed (LER, Chapter 1, Section 2, Article 117). These materials are not marketing materials, as their purpose is to support patients in their treatment rather than promote a medicine. While this requirement has been lifted, such materials should still include essential information and a clear prompt encouraging patients to read the patient information leaflet carefully. Product logos may be used in moderation as it helps patients recognize their medicine.
From now on, any reprinted materials must comply with the revised rules, and by 29 September 2026, all existing materials must be updated accordingly.
Mandatory Submission to IGN Limited to Marketing Materials
It has now been clarified that only materials intended for marketing purposes must be submitted as mandatory copies to the Information Review Board (IGN). Together with the Board for Assessment of Pharmaceutical Information (NBL), IGN oversees compliance with LER, conducting reviews both proactively and in response to complaints. Pharmaceutical companies are required to submit new marketing materials – such as brochures, advertisements, invitations, promotional videos or web content – within a reasonable time after the material has been put into use, and no later than three months (LER, Chapter 1, Section 1, Article 31 and Chapter 1, Section 2, Article 131).
This clarification was prompted by instances where companies have submitted materials that do not qualify as marketing. To avoid unnecessary submissions, only materials with a marketing purpose should be sent to IGN.
Extended Deadline for Reporting Collaborations
LER requires that companies report collaborations with healthcare professionals in Lif’s collaboration database. The deadline for such reporting has now been extended to three months after the implementation or start of the project (LER, Chapter 2, Section 1, Article 9 and Chapter 3, Section 1, Article 1).
Previously, reporting was required no later than the date of the activity or project start—a timeline that proved challenging for companies due to internal administrative processes. The extended deadline provides greater flexibility while maintaining transparency in industry–healthcare collaborations.
New Structure for Transparent Reporting of Transfers of Value
LER now requires companies to follow the structure outlined in the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) template for methodological notes when reporting transfers of value to healthcare (LER, Chapter 2, Section 3, Article 4). Starting with the publication in 2027 (covering transfers of value made in 2026), reports must also be searchable and downloadable from the time of publication.
This change reflects EFPIA’s updated requirements, which mandate the use of the template titled “Template of the methodological note structure” in the EFPIA Code of Practice, Annex B. The structured format applies from the 2026 publication of transfers of value made in 2025, and searchability becomes mandatory from 2027.
EFPIA is the European industry association representing research-based pharmaceutical companies. It sets ethical standards for interactions with healthcare professionals, healthcare organisations, and patient organisations through its Code of Practice. Lif is committed to abiding by these standards within LER.
It is important that companies in the pharmaceutical sector take note of these amendments to LER and update their internal procedures as needed to ensure continued compliance.
The Ethical Rules of the Pharmaceutical Industry are available here (in Swedish): lif.se/etik/etiska-regelverket
